Ketamine Effect on Recovery and Respiratory Outcomes After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
Phase: PHASE4
Conditions: Pain, Obesity, Hypoxia
Sponsor: Northwestern University

M. Yilmaz, M.D. 
 
 
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IRB # STU00081191  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: Sept. 29, 2019 
 
Title:  Ketamine Effect on Recovery and Respiratory Outcomes after Laparoscopic 
Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study 
 
NCT#: 
01997515 
 
Principle Investigator:  Meltem Yilmaz, MD 
 
Affiliation:  Department of Anesthesiology 
 
 
Northwestern University, Feinberg School of Medicine 
 
Institution: 
Northwestern Memorial Hospital 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

M. Yilmaz, M.D. 
 
 
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IRB # STU00081191  
 
 
 
 
 
Proposed Research Protocol Form 
Northwestern University Medical School 
Department of Anesthesiology  
 
Title:  Ketamine Effect on Recovery and Respiratory Outcomes after Laparoscopic 
Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study 
 
Principal Investigator: Meltem Yilmaz M.D.  
 
Affiliation: Department of Anesthesiology 
Northwestern University Feinberg School of Medicine   
 
Institution: Northwestern Memorial Hospital 
 
Research Aims:  
 
1. Research Questions(s):  Does Intraoperative Ketamine improve quality of 
recovery after laparoscopic gastric reduction surgery?  
2. Hypotheses:  Intraoperative ketamine will improve postoperative quality of 
recovery after laparoscopic gastric reduction.  
 
Research significance: 
 
Background:  
 
 
Laparoscopic surgery for gastric reduction is frequently associated with high 
levels of postoperative pain.1 Postoperative pain is very often treated with opioids. 
However large doses of opioids can result in respiratory depression with hypoxemia 
especially in high risk patients with obstructive sleep apnea.2  Since a large group of 
patients undergoing surgery for gastric reduction surgery also have obstructive sleep 
apnea, it is expected that these patients are also at high risk for postoperative respiratory 
depression and hypoxemia. 
 
 
Intraoperative ketamine has been used as an effective multimodal agent to reduce 
postoperative pain.3 However, ketamine alone has not been examined to improve 
postoperative pain outcomes in patients undergoing gastric reduction surgery. More 
importantly, it is unknown if the use of intraoperative ketamine can lead to better overall 
quality of recovery in the same patient population. In addition, ketamine has been shown 
to improve ventilation but it remains to be determined if the intraoperative use of 
ketamine will result in decreased postoperative opioid use and hence less complications 
such as hypoxic episodes within the first 24 hours after surgery.4,5 
 
 
The main objective of the current investigation is to examine the effect of 
intraoperative ketamine on postoperative quality of recovery after gastric reduction 

M. Yilmaz, M.D. 
 
 
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IRB # STU00081191  
 
 
 
 
surgery. We hypothesize that subjects receiving ketamine will have a greater global 
quality of recovery score than the ones receiving saline (placebo group). We also seek to 
determine if intraoperative ketamine would decrease the incidence of postoperative 
opioid requirements in the same patient population.  
 
Investigational Plan 
 
Study design: Randomized, double blinded placebo controlled clinical trial 
 
Methods: 
 
1. Primary outcome: QoR-40 at 24 hours6 
2. Size of study groups(s):   
It would be required to have 36 patients per group in order to achieve 80% power 
to detect a 10 point difference on the QoR-40 instrument with an estimated 
standard deviation of 15. To compensate for drop-outs or loss to follow-up, 80 
patients will be recruited and randomized. 
3. Secondary outcomes: 
Postoperative opioid consumption 
Postoperative pain scores 
Length of hospital stay (Hours) 
4. Patient entry, exclusion and dropout criteria: 
Entry: Age 18-64, surgery: laparoscopic gastric reduction (gastric sleeve or 
gastric bypass), ASA I, II, III; BMI >35kg/m2, Fluent in English  
Exclusion: History of allergy to protocol medications, History of chronic opioid 
use, pregnant patients. 
5. Drop out: Conversion to an open surgical route, patient or surgeon request. 
 
6. Protocol specific methods: Patients will be recruited on the day of surgery. 
Informed consent will be signed. Participant will complete the preoperative QoR-
40 questionnaire (appendix 1) along with the Stop-BANG questionnaire 
(appendix 2).  All medication except for propofol will be dosed based on the 
adjusted body weight (ABW=Ideal body weight (IBW) + [0.4 X (actual body 
weight –IBW)]8 Patients will be randomized using a computer generated table of 
random number to 2 groups: Group K (ketamine) will receive 0.5mg /kg  of 
ketamine bolus followed by an infusion of  0.5 mg/kg/hour of ketamine 
throughout the intraoperative period. Group P (placebo) will receive the same 
amount of saline. The investigators will be blinded to study drug. The medication 
will be prepared by the hospital pharmacy and is not involved with the case or 
data collection. 
 
Subjects will be premedicated with midazolam (0.02-0.04 mg/kg IV 
preoperatively. Routine ASA monitors will be applied. Anesthesia will be induced 
with remifentanil infusion started at 0.1 mcg/kg/minute titrated to keep blood 
pressure within 20% of the baseline and propofol 1.5 -2.5 mg/kg. Tracheal 
intubation will be facilitated with succinylcholine (1-2 mg /kg). Anesthesia will 

M. Yilmaz, M.D. 
 
 
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be maintained with sevoflurane titrated to a bispectral index (BIS) between 40-60, 
remifentanil infusion started at 0.1mcg/kg/min titrated to keep blood pressure 
within 20 % of baseline values, and neuromuscular blockade will be maintained 
with rocuronium that will be administered at the discretion of the anesthesiologist. 
Upon termination of the surgery, residual neuromuscular blockade will be 
antagonized with a combination of neostigmine 0.05mg/kg (to a maximum dose 
of 5mg) and glycopyrrolate 0.01 mg/kg . Remifentanil will be discontinued at the 
time of the removal of the laparoscope from the abdomen and hydromorphone 10 
mcg/kg IV will be administered. Ondansetron 4 mg IV and dexamethasone 4 mg 
IV will be administered to prevent postoperative nausea and vomiting. Study drug 
will be discontinued at the end of the surgical procedure as the dressings are being 
placed. Normothermia will be maintained intraoperatively using a forced air 
warming blanket (Bairhugger, Arizant healthcare INC, Eden Prairie, MN).  
Subjects will receive IV Hydromorphone in divided doses as needed to achieve a 
verbal rating score for pain <4 out of 10 starting in the operating room following 
extubation and in PACU.  Metoclopramide (10 mg IV) will be used as rescue 
antiemetic. Patient-controlled analgesia, programmed to deliver 0.2 mg of 
hydromorphone every 10 minutes, will be instituted before the patient is 
discharged from  the PACU.  Before PACU discharge, the LSD ARCI 
questionnaire7 (appendix 3) will be completed by the patient to assess for other 
untoward effects of ketamine. Ketorolac 30 mg every 6 hours for 24 hours will be 
started when admitted to patient room. SpO2 will be monitored continuously for 
24 hours after discharge from PACU. At 24 hours after surgery patients will 
complete the QoR-40  (appendix 1) instrument. 6   
 
Risks/Benefits: Participants may not have any direct benefit from taking part in this 
study.  Taking part in this study may help us determine whether the study drug increases 
24 hour quality of recovery and decreases opioid requirements within 24 hours of the 
surgery.  
  
Side effects of ketamine  
The common side effects of the study drug ketamine include:  
 
Most Frequent: 
Delirium 
Hallucinations 
Mood changes 
Nightmares 
Tachyarrhythmia  
Tonic- Clonic Epilepsy  
Vocalization 
 
Less Frequent: 
Bradycardia  
Hypotension 

M. Yilmaz, M.D. 
 
 
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Respiratory Depression 
Vomiting 
 
Rare: 
Anaphylaxis  
Anorexia  
Conduction disorder of the heat 
Diplopia  
Injection site 
Laryngismus 
Nausea 
Nystagmus  
Obstructive pulmonary disease 
Skin inflammation 
Skin rash 
 
Normal Saline (placebo): 
Hypernatremia  
 
These side effects are uncommon with the lower dose range used in this study. 
 
There is a risk of loss of confidentiality even though there are strict measures in place 
to prevent occurrence. Answering some of the questionnaires or surveys may make 
subject feel uncomfortable. The subject may skip to the next question if the question 
upsets them. There is a very slight risk of skin irritation from the pulse oximeter 
(Konica Minolta).  
 
Confidentiality: Subjects’ identity will be guarded by assigning a numerical code 
which is only known by the principal investigator and research coordinator. Data will 
be stored in department computer which is password protected. Each study subject 
will be assigned a study code number. The code will be used to link study data to 
patient identification (name) in a separate database. Subject data will be stored on 
secure computers at Northwestern University. Data access will be password protected 
and only available to study investigators. The data forms will be de identified after the 
chart review prior to analysis. 7 years post manuscript completion the data both 
electronic and paper will be destroyed using current departmental approved methods 
of destruction. 
 
Literature:  
 
1) 
Albrecht E, Kirkham KR, Endersby RV, Chan VW, Jackson T, Okrainec A, Penner T, Jin R, Brull R. 
Ultrasound-Guided Transversus Abdominis Plane (TAP) Block for Laparoscopic Gastric- Bypass Surgery: a 
Prospective Randomized Controlled Double-Blinded Trial. Obes Surg. 2013 Aug; 23(8); 1309-1314. PMID: 
23591549 
2) 
Porhomayon J, Leissner KB, El-Solh AA, Nader ND. Strategies in Postoperative Analgesia in the Obese 
Obstructive Sleep Apnea Patient. Clin J Pain. 2013 Nov; 29(11): 998-1005. PMID: 23370080 

M. Yilmaz, M.D. 
 
 
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3) 
Jouguelet-Lacoste J, La Colla L Schilling D, Chelly JE. The use of Intravenous Infusion of Single Dose of 
Low-Dose Ketamine for Postoperative Analgesia: A review of the Current Literature. Pain Med 2015; Feb;16 
(2): 383-403. PMID: 25530168 
4) 
Brown DL Use of ketamine to wean a patient with sleep apnea. Crit Care Med. 1986 Feb;14(2):167-168. 
PMID: 3943324 
5) 
De Oliveira Jr. GS, Fitzgerald PC, Ahmad S, Hansen N, McCarthy RJ. The effect of ketamine on 
hypoventilation during deep sedation with midazolam and propofol: a randomized, double-blind, placebo- 
controlled trial.in patients undergoing deep sedation. A randomized placebo controlled trial. Eur. J. 
Anaesthesiol. 2014 Dec; 31(12): 654-662. PMID: 24247410 
6) 
De Oliveira GS Jr, Fitzgerald P, Streicher LF, Marcus RJ, McCarthy RJ. Systemic lidocaine to improve 
postoperative quality of recovery after ambulatory laparoscopic surgery. Anesth Analg. 2012 Aug; 
115(2):262-267. PMID: 22584558 
7) 
Haertzen CA, Hickey JE. (1987) Addiction Research Center Inventory (ARCI): measurement of euphoria and 
other drug effects. Chapter 24. In Bozarth, MA (Ed.), Methods of assessing the reinforcing properties of 
abused drugs (pp. 389-524). New York: Springer-Verlag.  
 
8) 
Han PY, Duffull SB, Kirkpatrick CM, Green B. Dosing in obesity: a simple solution to a big problem. Clin 
Pharmacol Ther. 2007 Nov; 82(5):505-508. PMID: 17952107 
 
9) 
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 Jan; 84: 11-15. PMID: 10740540 
 
10) Chung F, Abdullah HR, Lao P. STOP-Bang Questionnaire: A Practical Approach to Screen Obstructive Sleep 
Apnea. Chest. 2016 Mar; 149 (3); 631-638. PMID: 266378880 
 
 
 
 
 

M. Yilmaz, M.D. 
 
 
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Appendix 1  QOR-40 
 
Modified Quality of Recovery Survey: MQoR-40  Study Patient Number: _________ 
                                                                    
 
Date of Surgery: ___ / ___ / ___ 
How have you been feeling in the last  24 hours? (please circle one) 
 
 
None of 
the time 
Some of 
the time 
Usually 
Most of 
the time 
All of 
the time 
COMFORT 
Able to breathe easily 
 
Have had a good sleep 
 
Able to enjoy food 
 
Feel rested 
 
   1 
 
   1 
 
   1 
 
   1 
 
   2 
 
   2 
 
   2 
 
   2 
 
   3 
 
   3 
 
   3 
 
   3 
 
   4 
 
   4 
 
   4 
 
   4 
 
   5 
 
   5 
 
   5 
 
   5 
EMOTIONS 
Have a feeling of general well-being 
 
Feel in control 
 
Feel comfortable 
    
   1 
 
   1 
 
   1 
 
   2 
 
   2 
 
   2 
 
   3 
 
   3 
 
   3 
 
   4 
 
   4 
 
   4 
 
   5 
 
   5 
 
   5 
 
 
 
 
 
 
PHYSICAL INDEPENDENCE 
Have normal speech 
 
Able to wash, brush teeth, shave 
 
Able to look after your own appearance 
 
Able to write 
 
Able to return to work/usual home activities 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
 
 
 
 
 
PATIENT SUPPORT 
Been able to communicate with MD 
 
Able to communicate with family / friends 
 
Able to communicate with visiting healthcare 
worker  
 
Have support from family / friends 
 
Have support from visiting healthcare worker  
 
Able to understand instructions and advice 
 
   1 
 
   1 
 
   1 
 
   
   1 
 
   1 
 
   1 
 
   2 
 
   2 
 
   2 
 
 
   2 
 
   2    
 
   2 
 
   3 
 
   3 
 
   3 
 
    
   3 
 
   3 
  
   3  
 
   4 
 
   4 
 
   4 
 
    
   4 
 
   4 
 
   4 
 
   5 
 
   5 
 
   5 
 
  
   5 
 
   5 
 
   5 
 
 
 
 
 
 
 

M. Yilmaz, M.D. 
 
 
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Have you had any of the following in the last 24 hours? (please circle one) 
 
 
None of 
the time 
Some of 
the time 
Usually 
Most of 
the time 
All of 
the time 
COMFORT 
Nausea 
 
Vomiting 
 
Retching 
 
Feeling restless 
 
Shaking / twitching 
 
Shivering 
 
Feeling cold 
 
Feeling dizzy 
    
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
 
 
 
 
 
EMOTIONS 
Had bad dreams 
 
Feeling anxious 
 
Feeling angry 
 
Feeling depressed 
 
Feeling alone 
 
Had difficulty falling asleep 
    
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
    
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
    
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
    
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
    
 
 
 
 
 
 
PATIENT SUPPORT 
Feeling Confused 
 
   5 
   
   4 
 
   3 
 
   2 
 
   1 
 

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None of 
the time 
Some of 
the time 
Usually 
Most of 
the time 
All of 
the time 
PAIN 
Moderate pain 
 
Severe pain 
 
Headache 
 
Muscle pains 
 
Backache 
 
Sore throat 
 
Sore mouth 
    
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
Please check that all questions have been answered. 
 
Thank you for your assistance.      
 
 
Date: ___ / ___ / ___ 
 
Time: ________  AM / PM 
 
 
 
 
 
 
 
 

M. Yilmaz, M.D. 
 
 
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Appendix  2 (STOP-Bang Questionnaire) 
 
STOP-Bang Questionnaire 
 
 
YES NO 
Snoring:  
Do you snore loudly (loud enough to be heard through closed 
doors)? 
 
 
Tired:  
Do you often feel tired, fatigued, or sleepy during daytime? 
 
 
Observed:  
Has anyone observed you stop breathing during your sleep? 
 
 
Blood pressure:  
Do you have or are you being treated for high blood pressure? 
 
 
BMI: more than 35 kg m−2? 
 
 
Age: over 50 year old? 
 
 
Neck circumference: >40 cm? 
 
 
Gender: Male? 
 
 
Total Score 
 
PACU Desaturation 
 
 
High risk of OSA: Yes to ≥3 questions. 
Low risk of OSA: Yes to <3 questions.  
Chung F, et al: BJA 2012; 108: 768-75 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 3 (LSD ARCI) 7 
 
LSD_ARCI Questionnaire 
 
Question 
True 
False 
My hands feel clumsy 
 
 
 
I have a weird feeling 
 
 
 
I have an unusual weakness of my muscles 
 
 
 
Some parts of my body are tingling 
 
 
 
I feel anxious and upset 
 
 
 
I have a disturbance in my stomach 
 
 
 
A thrill has gone through me one or more times since I started 
the test 
 
 
 
I notice my hand shakes when I try to write 
 
 
 
I feel an increasing awareness of my bodily sensations 
 
 
 
It seems I’m spending longer than I should on each of these 
questions 
 
 
 
 
 
 

M. Yilmaz, M.D. 
 
 
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Appendix 3  QOR-40 
 
Modified Quality of Recovery Survey: MQoR-40  Study Patient Number: _________ 
                                                                    
 
Date of Surgery: ___ / ___ / ___ 
How have you been feeling in the last  24 hours? (please circle one) 
 
 
None of 
the time 
Some of 
the time 
Usually 
Most of 
the time 
All of 
the time 
COMFORT 
Able to breathe easily 
 
Have had a good sleep 
 
Able to enjoy food 
 
Feel rested 
 
   1 
 
   1 
 
   1 
 
   1 
 
   2 
 
   2 
 
   2 
 
   2 
 
   3 
 
   3 
 
   3 
 
   3 
 
   4 
 
   4 
 
   4 
 
   4 
 
   5 
 
   5 
 
   5 
 
   5 
EMOTIONS 
Have a feeling of general well-being 
 
Feel in control 
 
Feel comfortable 
    
   1 
 
   1 
 
   1 
 
   2 
 
   2 
 
   2 
 
   3 
 
   3 
 
   3 
 
   4 
 
   4 
 
   4 
 
   5 
 
   5 
 
   5 
 
 
 
 
 
 
PHYSICAL INDEPENDENCE 
Have normal speech 
 
Able to wash, brush teeth, shave 
 
Able to look after your own appearance 
 
Able to write 
 
Able to return to work/usual home activities 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
 
 
 
 
 
PATIENT SUPPORT 
Been able to communicate with MD 
 
Able to communicate with family / friends 
 
Able to communicate with visiting healthcare 
worker  
 
Have support from family / friends 
 
Have support from visiting healthcare worker  
 
Able to understand instructions and advice 
 
   1 
 
   1 
 
   1 
 
   
   1 
 
   1 
 
   1 
 
   2 
 
   2 
 
   2 
 
 
   2 
 
   2    
 
   2 
 
   3 
 
   3 
 
   3 
 
    
   3 
 
   3 
  
   3  
 
   4 
 
   4 
 
   4 
 
    
   4 
 
   4 
 
   4 
 
   5 
 
   5 
 
   5 
 
  
   5 
 
   5 
 
   5 
 
 
 
 
 
 
 

M. Yilmaz, M.D. 
 
 
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Have you had any of the following in the last 24 hours? (please circle one) 
 
 
None of 
the time 
Some of 
the time 
Usually 
Most of 
the time 
All of 
the time 
COMFORT 
Nausea 
 
Vomiting 
 
Retching 
 
Feeling restless 
 
Shaking / twitching 
 
Shivering 
 
Feeling cold 
 
Feeling dizzy 
    
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
 
 
 
 
 
EMOTIONS 
Had bad dreams 
 
Feeling anxious 
 
Feeling angry 
 
Feeling depressed 
 
Feeling alone 
 
Had difficulty falling asleep 
    
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
    
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
    
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
    
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
    
 
 
 
 
 
 
PATIENT SUPPORT 
Feeling Confused 
 
   5 
   
   4 
 
   3 
 
   2 
 
   1 
 

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None of 
the time 
Some of 
the time 
Usually 
Most of 
the time 
All of 
the time 
PAIN 
Moderate pain 
 
Severe pain 
 
Headache 
 
Muscle pains 
 
Backache 
 
Sore throat 
 
Sore mouth 
    
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   5 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   4 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   3 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   2 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
   1 
 
Please check that all questions have been answered. 
 
Thank you for your assistance.      
 
 
Date: ___ / ___ / ___ 
 
Time: ________  AM / PM