A Randomized Trial of Deep Neuromuscular Blockade Reversed With Sugammadex Versus Moderate Neuromuscular Block Reversed With Neostigmine, on Postoperative Quality of Recovery
Phase: PHASE4
Conditions: Laparoscopy, Anesthesia Recovery Period
Sponsor: University of Melbourne

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Prof Colin Royse 
 
Study Title: 
  
A randomized trial of deep neuromuscular blockade reversed with sugammadex 
versus moderate neuromuscular block reversed with neostigmine, on postoperative 
quality of recovery 
Institution Name 
 
The University of Melbourne 
Investigator Contact 
Information: 
­ Full address  
­ Phone No. 
­ Fax  No. 
­ e-mail address 
Professor Colin Royse 
Department of Surgery 
LEVEL 6 Clinical Medical Research Building, The Royal Melbourne Hospital 
Post: PO Box 2135, RM 
H, Victoria 3050 
P: +61383445673 
M: +61408467548 
F: +61386794445 
E: colin.royse@unimelb.edu.au 
 
 
 

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Section #2- Core Protocol 
2.1 Objectives & 
Hypotheses  
 
 
 
 
Objectives 
 
1.  To identify whether the rate/quality of recovery is affected by deep neuromuscular 
block (DNB) and  reversal with sugammadex versus light/moderate neuromuscular 
block reversed with neostigmine in patients undergoing operative gynecological or 
abdominal laparoscopic surgery of at least 1-hour duration. 
 
 
Hypothesis 
 
1.  The technique of deep neuromuscular block and  reversal with sugammadex will 
result in improved quality of recovery, including cognition, compared to the current 
standard of care technique using light/moderate neuromuscular block reversed with 
neostigmine in patients undergoing operative gynecological or abdominal 
laparoscopic surgery of at least 1-hour duration. 
 
 
2.2 Background & 
Rationale, 
Significance of 
Selected Topic & 
Preliminary Data  
 
Importance and assessment of quality of recovery 
 
Recovery following general anesthesia is a complex issue confounded by the type of 
surgery, inflammation, different anesthetic drugs and techniques, patient co-
morbidities, and differing patient and clinician perceptions of what constitutes good 
recovery. 
 
Recovery is not a single entity but rather covers many aspects or domains such as 
physiological recovery, pain and nausea, emotion and mood, return to normal life or 
work activities, and cognitive function.  It is an entity that is difficult to quantify, which 
then makes it difficult to study in a systematic manner. For anesthesiologists, poor 
recovery is often relayed by the surgeon days or weeks after the event, and it is 
usually categorized as an adverse outcome. 
 
Research tools such as the Aldrete (1)  or the QoR (2, 3)   scales, focus on early 
physiological recovery,  or the immediate perioperative period.   These recovery 
scores are not sensitive enough to measure the rate of recovery (change over time), 
and have not been designed for repeated measures. They are also inadequate to 
identify poor cognitive recovery. 
 
In 2007, an international group of anesthesiologists and neuropsychologists formed 
an advisory board to create a new quality of recovery scale. The aim was to produce 
a tool that was simple to perform, but sensitive enough to detect change in multiple 
domains of recovery over time. The initial validation experiment included over 700 
patients, and this work has been published in Anesthesiology. It is called the 
Postoperative Quality Recovery Scale (PostopQRS)(4).   Six domains of recovery 
are identified: physiological, nociceptive (pain and nausea) emotive (anxiety and 
depression), functional recovery (return of activities of daily living), cognitive 
recovery, and an overall patient perspective domain including satisfaction. The scale 
is completed prior to surgery to provide baseline values, and then repeated at user-
defined intervals. From some of the subsequent discriminant validation studies, time 
points have included early and late measures such as 15 minutes, 40 minutes, 1 and 
3 days, and 3 months after the completion of anesthesia (typically defined as after 
the last surgical stimulation). Recovery is broadly defined as return to baseline 
values or better, except for the cognitive domain where a tolerance factor is included 
to allow for normal performance variability, such that patients are allowed to perform 

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a little worse than baseline as still be scored as recovered (5).  Because repeated 
tests tend to have a learning effect, the cognitive domain uses parallel forms, and 
only a small learning has been shown (5).  
 
One of the most important benefits of the PostopQRS scale is that it enables 
recovery to be quantified and measured. This makes it possible to compare different 
interventions with the express purpose of developing clinical interventions to improve 
quality of recovery. The PostopQRS offers a tool to provide the recovery process to 
be examined. There are no other tools in existence that provide a comprehensive, 
sensitive assessment of the multiple aspects or domains of recovery, and is yet 
relatively simple to perform. Validation studies have been performed and show good 
discriminative ability (5-8). Ease of use is facilitated by using a web based data entry 
system and the ability to use the telephone to conduct surveys after discharge form 
hospital. Telephone survey has been shown to be equivalent to face to face 
interviews using the PostopQRS (5). Further, the PostopQRS allows users to drill 
down to identify which recovery domain is affected for individuals in real time as well 
as for group audit. 
 
Quality of recovery after operative laparoscopy 
 
The majority of the literature compares different operative techniques with outcome 
measures aimed at specific complications or length of stay. Few studies include 
quality of recovery or quality of life measures as secondary endpoints (9-12). 
However, for potential benefits relating to the use of sugammadex, there are a few 
studies primarily centered around deep neuromuscular block (DNB) facilitating low 
intraabdominal inflation pressures. Most outcomes relate to operative conditions with 
little data on patient centered outcomes especially after discharge.  The inclusion of 
sugammadex is to permit the use of DNB, and most comparative groups (of 
moderate block) are reversed with neostigmine.  
 
It has been shown that more patients can be operated on with low intraabdominal 
pressure with DNB, and that operative conditions are rated as better in more patients 
with DNB (13, 14), though it is not absolute and there are frequent crossovers. That 
is, there are patients with moderate block and low pressure, and equally patients 
with DNB requiring high inflation pressures. The very few data on patient centered 
outcomes show reduced pain and nausea after DNB (13, 15-17), but lack of 
evidence of benefit for other recovery outcomes. This paucity of data has been 
stressed by review articles and editorials that DNB is associated with a modest effect 
on improving operating conditions but very little data to identify recovery benefits (13, 
18) 
 
Sugammadex is an effective drug to reduce deep neuromuscular blockade 
 
There is no clinical question that sugammadex is highly effective in reversing 
neuromuscular blockade with rocuronium or vecuronium. This has been the subject 
of a Cochrane review which included 18 randomized trials, showing that 
sugammadex can reverse blockade with rocuronium or vecuronium independent on 
the depth of block, and superiority to neostigmine (19). This aspect of sugammadex 
does not require further study. This translates to a low incidence of residual blockade 
in the PACU compared to neostigmine reversal. The "safety" benefit to using 
sugammadex has been proven, but this does not necessarily translate into better 
outcomes. Sugammadex, however, is an enabling drug to facilitate deep 
neuromuscular blockade, allowing the anesthesiologist to continue that block until 
the end of surgery and reliably reverse the block. This is just not possible with 
neostigmine reversal, as one must wait until a train of four count of at least 2 
twitches (or TOF ratio > 0.7) to safely reverse the block with neostigmine. 

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Sugammadex is not a single intervention 
 
The role of sugammadex as a single intervention can only be applied when reversing 
neuromuscular block, when the block is moderate and a TOF 0.7 is achieved, with 
the outcome restricted to reversal of blockade. 
 
When sugammadex is used as a tool to facilitate deep muscular block, the 
intervention is principally the DNB rather than sugammadex. In any randomized trial 
comparing sugammadex with neostigmine for reversal of DNB, the extra time that 
anesthesia is continued in the neostigmine group will be a confounder on post-
operative outcomes. In a study comparing sugammadex vs. neostigmine to reverse 
DNB, the anesthetic time in the neostigmine group was almost double that of the 
sugammadex group (47 vs 95 min) (20). This markedly increased anesthetic 
duration was due to the time taken for the TOF ratio to exceed 0.9 and facilitate safe 
extubation. It is therefore not possible to examine the issue of deep neuromuscular 
block and unbundle sugammadex from the anesthetic technique required. 
 
Outcomes and confounders when assessing post-operative quality of recovery
There are a few data assessing the impact of anesthetic drugs rather than surgical 
techniques or different operations on the post-operative quality recovery. It is very 
likely that different anesthetic drugs may independently contribute to changes in 
post-operative quality of recovery, over and above the use of deep neuromuscular 
block for laparoscopic surgery.   
 
The two most commonly used anesthetic drugs are propofol and sevoflurane. Both 
are relatively short acting drugs, but have a wide variation of offset, particularly with 
more prolonged anesthesia, and patient factors such as morbid obesity (21-23). 
Desflurane is a volatile agent which is very short acting, and more importantly has 
highly predictable offset, which is independent of patient factors such as obesity (21) 
or of operation duration. In patients receiving moderate neuromuscular block and 
reversal with neostigmine, the use of desflurane lead to earlier response to 
command and return of airway reflexed compared to sevoflurane (24). 
 
Our research group is currently conducting research into different anesthetic 
techniques. Previously, we studied effect of desflurane vs.  propofol in patients 
undergoing cardiac surgery, and showed less cognitive dysfunction one week after 
surgery but not at three months after surgery with desflurane (25). We have recently 
concluded but not published a pilot study investigating propofol sedation vs. 
desflurane general anesthesia to supplement spinal anesthesia for total hip 
replacement. The participant numbers are too small for meaningful statistical 
analysis, but there is a trend towards improved recovery and better cognitive 
recovery in the desflurane group (absolute difference 15% and OR 2.3). What is 
interesting, though, is that the early differences were negligible, and the trend 
occurred at 1 month and 3 months after surgery. 
 
The recovery graphs for the PostopQRS are shown below.  The Y axis is the 
proportion of patients recovered for each domain, and the X axis shown the time 
points where the PostopQRS was conducted.  
 
 
 

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Our data cannot explain why there were differences late rather than early. However, 
the cognitive domain is very sensitive to pain, analgesics and inflammation, and it is 
possible that modest but clinically important differences could be masked early after 
surgery by these factors, and only become evident after the inflammation and 
requirement for analgesia ceases. There were no intermediate time points between 3 
days and 1 month, so we cannot be sure when this possible effect is starting.  
 
We are conducting a blinded study for sevoflurane vs. desflurane for knee 
arthroscopy and measuring recovery using the PostopQRS. However, we performed 
a blinded interim analysis, which shows group separation of around 10% in recovery 
15 mins
40 mins
1 day
3 days
1 month
3 months
0
20
40
60
80
100
Post-operative time points
% of patients recovered
Cognitive recovery
Propofol
Desflurane
A
15 mins
40 mins
1 day
3 days
1 month
3 months
0
20
40
60
80
100
Post-operative time points
% of patients recovered
Physiological recovery
Propofol
Desflurane
C
15 mins
40 mins
1 day
3 days
1 month
3 months
0
20
40
60
80
100
Post-operative time points
% of patients recovered
Emotive recovery
Propofol
Desflurane
E
15 mins
40 mins
1 day
3 days
1 month
3 months
0
20
40
60
80
100
Post-operative time points
% of patients recovered
Overall recovery
Propofol
Desflurane
B
15 mins
40 mins
1 day
3 days
1 month
3 months
0
20
40
60
80
100
Post-operative time points
% of patients recovered
Nociceptive recovery
Propofol
Desflurane
D
15 mins
40 mins
1 day
3 days
1 month
3 months
0
20
40
60
80
100
Post-operative time points
% of patients recovered
ADL recovery
Propofol
Desflurane
F

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and cognitive domain at the 1-month time point, but not at earlier or later time points.  
The cognitive domain is shown below: 
 
 
Further, it is possible that other components of the anesthetic technique such as 
analgesia could also be a confounder in recovery. 
 
The importance of the anesthetic confounders, is that is not possible to unbundle 
sugammadex from the anesthetic and still provide deep block, due to the much 
longer anesthesia time if neostigmine is used.  
 
The concept of anesthetic bundles of technique 
 
This introduces the concept of bundling agents together which have similar offset 
properties, and comparing that to real-world practice of light/moderate block, reversal 
with neostigmine and typically using sevoflurane as the maintenance anesthetic. The 
group receiving short acting drugs should have much less variance between 
effective block reversal and emergence, whilst at the same time facilitate optimal 
operating conditions. The coupling of agents should provide the greatest group 
separation for the use of sugammadex and potentially for postoperative quality 
outcomes. 
 
In this study, we wish to primarily investigate the effect of the role of DNB, and to 
reduce the potential for confounding from different anesthetic techniques, we will 
standardize the anesthetic to use the shortest acting anesthetic bundle, and use 
desflurane coupled with short acting opiates and multimodal analgesia in patients 
undergoing operative gynecological or abdominal laparoscopic surgery of at least 1-
hour duration.  
 
The research team 
The team will be managed by Prof Colin Royse at the University of Melbourne. Colin 
is one of the founders of the PostopQRS and is the co-director of the group. We aim 
to recruit centers with high volume of operative gynecological or abdominal 
laparoscopic surgery. The University of Melbourne department is co-located with the 
Royal Melbourne Hospital and the Royal Women’s Hospital, and connected to our 
specialist cancer hospital the Peter MacCallum Cancer Center. We also have access 
to a private hospital (Northpark Private Hospital) which has a high volume of 
gynecological surgery. These centers will be the initial target hospitals with potential 
to expand the number of hospitals once the trial is underway. The team statistician is 

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Dr. Sandy Clarke, Statistical Consulting Centre, Department of Mathematics, The 
University of Melbourne. 
 
Clinical significance 
 
Quality of recovery is an emerging field within anesthesia of great importance.  
Although large outcome studies are very important in anesthesia, there is a changing 
focus from “mortality and morbidity studies”, to quality of recovery. The reason is that 
the frequency of mortality is now very low with the result that few interventions will 
further reduce mortality and in any event very large numbers will be required to 
demonstrate any improvements in surgery and anesthesia with mortality as an 
outcome. However early data on the PostopQRS as well as clinical reports indicate 
that the quality of recovery is often poor in many patients, and yet these are not 
identified by the treating anesthesiologist.  There are implications for the individual 
patient, for the practice of anesthesia, and for the community (such as safe return to 
work or to driving).  
 
If providing deep neuromuscular block does lead to improved quality outcomes, then 
it is essential to use sugammadex to reverse the block. There may be benefits (such 
as cognitive recovery) that may be worsened by drugs such as neostigmine and 
avoidance of neostigmine may be a mechanism of improving recovery. The coupling 
of drugs with similar offset times may further lead to improved quality of recovery. 
 
2.3 Study Design 
 
Study design 
 
Parallel randomized trial with allocation ration 1:1. The trial will be registered prior to 
commencement and will conform too CONSORT guidelines. 
 
Study environment 
 
The study will be conducted in a secondary or tertiary hospitals, which have an active 
laparoscopic surgery unit for gynecology or abdominal surgery.  It is anticipated that a 
24-month study period will be required.  The combined institutions conduct more than 
40 elective operative laparoscopies per week, making an average of 8 patients per 
week recruitment very feasible to achieve.  Additional study sites will be added to 
increase recruitment if required.  
 
Eligibility criteria 
 
Inclusion: 
1. Adult participants undergoing operative gynecological or abdominal surgery 
under general anesthesia of at least 1 hour duration 
 
Exclusion: 
1. Participants, who are not fluent in English will be excluded, as they may be 
unable to answer the recovery questionnaire adequately.  
2. Participants undergoing diagnostic laparoscopy only 
3. Participants <18 years of age 
4. Current pregnancy 
5. Known allergy to rocuronium, neostigmine or sugammadex, or desflurane  
 

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2.4 Study Flowchart 
 
2.5 Study 
Procedures 
Interventions 
 
Common management will include the following 
 
1. Pre-medication other than oral analgesic (such as paracetamol) will not be used. 
 
2.  Induction will be with intravenous propofol, including co-induction consisting of 
fentanyl 0.5-3.0 mcg/kg, or equivalent short acting opiate including remifentanil. 
 
3. Analgesia will consist of multimodal analgesia as determined by the 
anesthesiologist to treat the degree of pain, but in principle to avoid long acting 
opiates, e.g. use intraoperative short acting opiates, 1 g acetaminophen qid, 
NSAID’s including Cox II inhibitors (such as paracoxib 40mg i.v.), or oxycontin 10-
20mg 6 hourly.  
 
4. Dual antiemetic therapy as per hospital guidelines 
 
5. The maintenance anesthetic will be desflurane, and will be titrated to effect by the 
attending anesthesiologist 
 
6. Rocuronium administration: for moderate neuromuscular block an initial dose of 
0.6 mg/kg, with repeat doses of 0.15mg/kg given if the TOF >2 twitches. After 
completion of the majority of surgical resection, the level of block may be reduced to 
at least 3 twitches in preparation for  the end of surgery. 
 
 For DNB, the initial dose will be 1.2 mg/kg and repeat doses of 0.15 mg/kg until PTC 
≤ 2. TOF counts may be checked as frequently as every 15 seconds, but the PTC 
count interval must be at least 2 minutes (26).  
 
7.  If vecuronium ( a similar steroidal muscle relaxant) is used instead 
of  Rocuronium, then the dose is reduced to 10% of  the dose of rocuronium, and 
titrated to achieve the same TOF endpoints.  
 
8. Reversal of neuromuscular block 
 
a. Neostigmine 50 micrograms/kg coupled with atropine 20 micrograms/kg or 
glycopyrrolate 5 micrograms/kg, to a maximum dose of neostigmine of 5.0 mg. The 
neostigmine should not be administered until the TOF has at least 3 twitches 
present. 
 
 
b. Sugammadex dosage will be adjusted to body weight and PTC/TOF count 
at the time of reversal, and not administered until PTC at least 1. Dosage will be 
4mg/kg if TOF = 0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1. 
 
9. Extubation for all groups will occur when the TOF has 4 twitches with no visible 
fade, (or a TOF ratio > 0.7 for institutions using a TOF ratio measurement device) 
adequate respiration and degree of alertness as determined by the anesthesiologist 

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as safe for extubation. Patients  should not leave the operation room until  TOF has 
4 twitches with no visible fade, or for institutions using a TOF ratio measurement 
device, a TOF ratio > 0.9. 
 
 
Intervention –groups 
 
 
1. ModNB  - participants will receive moderate neuromuscular blockade with 
rocuronium aiming for TOF  0-2 twitches, with neostigmine reversal when the TOF at 
least 3 twitches. After completion of the majority of surgical resection, the levl of 
block may be reduced to at least 3 twitches in preparation for  the end of surgery. 
 
 
2. DNB– participants will receive DNB aiming for a post tetanic count of 1-2, which 
will be maintained until removal of the laparoscopic ports, with reversal using 
sugammadex.  
 
 
Study assessments protocol 
 
Quality of recovery will be assessed using the Postoperative Quality of Recovery 
Scale (PostopQRS) see www.postopqrs.com. The survey takes around 5-6 minutes 
on each occasion to administer and is conducted either face-to-face whilst the 
participant is in hospital or via the telephone when discharged. Five recovery 
domains are assessed (physiological, nociceptive, emotive, function (ADL) and 
cognitive, and an additional overall patient perspective domain is recorded including 
satisfaction. 
 
The scale will be conducted prior to surgery (baseline) and at 15 mins, 40 mins, 1 
and 3 days, 1 and 2 weeks, 1 and 3 months after surgery to track recovery from the 
immediate to long-term. 
 
Outcome measurements  
 
Primary outcome 
 
The most sensitive recovery domain of the Postoperative Quality of Recovery Scale 
to the effects of short acting drugs and avoidance of neostigmine is cognition. The 
primary outcome will be the cognitive domain at 1 week after surgery, when it is 
expected that most of the acute inflammation will have resolved, and analgesia 
requirements minimal.   
 
Secondary outcomes 
1. Recovery for all domains and within domains at the other time points of 
measurement (15 minutes, 40 minutes 1 day, 3 days, 1 and 2 weeks, and 3 months 
following cessation of anesthesia). The domains of recovery are physiological, 
nociceptive, emotive activities of daily living, cognitive and overall patient 
perspective. 
 
2. Compliance with protocol to ensure deep block or light/moderate block, and 
correctly assigned anesthetic.  
 
3. Anesthesia, surgical (first incision to last stitch), operating room, and PACU times, 
and hospital length of stay 
 

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4.  Incidence of persistent neuromuscular block (TOF < 4 twitches or visible fade, or 
TOF ratio < 0.9) upon arrival in the PACU. 
 
5. Surgical operating conditions measured by maximal inflation pressure required for 
surgery, and number of times that organ movement occurred (due to diaphragmatic 
movement or abdominal wall tone), and overall surgical satisfaction using a 1-5 
Likert scale (1 = very unacceptable, 2 = unacceptable, 3 = acceptable, 4 = good, 5 = 
excellent). 
 
Ethical issues 
 
This study will be reviewed by the Melbourne Health HREC. All patients will receive 
a written plain language statement and will provide informed written consent. 
 
Both  neuromuscular reversal drugs are commonly used in Australia. If the 
participating anesthesiologist believes that the anesthetic regimen is inappropriate, 
then the patient will not be recruited into the study. The concept of deep 
neuromuscular block is relatively new in laparoscopic surgery as it can only be safely 
performed if reversal can be reliably achieved in an acceptable time frame. 
Accordingly, the deep neuromuscular block group will receive sugammadex using 
dosage guidelines according to body weight and degree of neuromuscular block at 
the time of reversal.  Each PostopQRS measurement takes approximately 5-10 
minutes, and is not onerous or stressful to the patient. However, if the patient does 
not wish to participate further, then they may withdraw from the study.  
Measurements performed after discharge from hospital are conducted via telephone 
interviews and do not require the patient to return to the hospital or other location. 
The interviews are arranged between the researcher and patient at a time of mutual 
convenience. 
 
 
 
2.6 Study Duration 
Anticipated time-line 
 
The aim is to recruit an average of 4-6 patients per week (at least 4 hospitals to 
participate, with potential to add more hospitals).  That timeline for the study 
schedule is listed below, though could advance earlier if recruitment is faster than 
anticipated.  
 
Objective 
3 months  
3-12 months  
12 -21 months 
21-24 
months  
Ethics 
XXXXXXXX 
 
 
 
Recruit 40% 
 
XXXXXXXXX 
 
 
Recruit 100% 
 
                  
XXXXXXXXX 
 
Complete 3 
month follow 
up 
 
 
 
XXXX 
Analysis and 
manuscript 
 
 
 
 
2.7 Statistical 
Analysis and 
Sample Size 
Justification  
 
The team statistician is Dr. Sandy Clarke, Statistical Consulting Centre, Department 
of Mathematics, The University of Melbourne, who will oversee the statistical analysis.
 
Study size 
Sample size estimates are based on the primary outcome of cognitive recovery at 1 
week after surgery, and a clinically important difference in cognitive recovery at 1 week 

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after surgery of 15%. Estimates of cognitive recovery are based on prior PostopQRS 
research and using multiple ages and surgical cohorts. It is estimated that the cognitive 
recovery for this cohort and duration of surgery will be 85% if there is good recovery. 
Using a two tailed estimate and Chi-squared analysis, alpha of 0.05, and power of 
90%, with 1:1 allocation ratio; the sample size required to detect an absolute difference 
of 15% is 161 per group, which will be rounded up to a total sample size of 350  patients 
to account for potential non-completion of the study 
 
Statistical methods 
 
Variables of “recovery” are dichotomized to "recovered" or "not recovered" based on 
whether they have achieved baseline values or better at each of the time points when 
measurement is performed. A tolerance factor is included in the scoring of cognitive 
recovery to allow for performance variability (5). Statistical analysis for the primary 
outcome will be with the Chi-squared test. For the secondary outcomes of recovery 
over time, analysis will be performed using the a general linear mixed model to 
investigate group differences over time. Continuous data will be analyzed using 
independent samples t test, or RM ANOVA for repeated measurements. A P<0.05 will 
define statistical significance, and P<0.01 will define statistical significance for 
secondary endpoints to reduce risk of Type I error. Analysis is intention to treat. 
 
Randomization 
 
The randomization sequence will be produced using a computer generated 
randomization sequence, in unequal blocks and stratified for gynecological and 
abdominal surgery. Concealment will be by placing the card containing the allocation 
information in double opaque sealed envelopes, and concealment will be maintained 
until after recruitment and the patients is admitted to the operating theatre. The treating 
anesthesiologist will then open the envelopes to reveal the allocation. A non-
participant in any process of the study will perform preparation of the envelopes. A 
copy of the randomization sequence will be stored in a separate databank, which is 
password protected and not available to the investigators until the study is complete.  
 
Blinding 
Due to the nature of the drugs, it is not possible to blind the treating anesthesiologist 
to the allocation, but the patient and study investigators who collect the PostopQRS 
data will be blinded to allocation. 
 
 
2.9 Adverse 
Experience 
Reporting 
A data monitoring committee will be established and chaired by a senior academic 
who is not part of the clinical trial conduct. Adverse events will be reported to the 
HREC. 
2.10 References 
References  
 
1. 
Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 
1970;49(6):924-34. 
2. 
Myles PS, Reeves MD, Anderson H, Weeks AM. Measurement of quality of 
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3. 
Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability 
of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000;84(1):11-
5. 

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4. 
Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, et al. 
Development and feasibility of a scale to assess postoperative recovery: the post-
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Knee surgery recovery: Post-operative Quality of Recovery Scale comparison of age 
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tonsillectomy: discriminant validation of the Postoperative Quality of Recovery Scale. 
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Abbas AE, Abd Ellatif ME, Noaman N, Negm A, El-Morsy G, Amin M, et al. 
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Abd Ellatif ME, Askar WA, Abbas AE, Noaman N, Negm A, El-Morsy G, et al. 
Quality-of-life measures after single-access versus conventional laparoscopic 
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Bansal VK, Misra MC, Babu D, Victor J, Kumar S, Sagar R, et al. A 
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Barkun JS, Wexler MJ, Hinchey EJ, Thibeault D, Meakins JL. Laparoscopic 
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Koo BW, Oh AY, Seo KS, Han JW, Han HS, Yoon YS. Randomized Clinical 
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Versus 
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Neuromuscular 
Block for Low-Pressure 
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Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Lindekaer AL, Riber C, 
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2005;100(3):697-700, table of contents. 
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2.12 Publication 
Plan 
 The main study will be aimed at Anesthesiology for the first submission. 
Presentations will be made at major international anesthesiology meetings