Emergence Agitation in Pediatrics After Dexmedetomidine vs. Sevoflurane Anesthesia: a Randomized Controlled Trial
Phase: NA
Conditions: Emergence Delirium
Sponsor: Pelita Harapan University

 
 
1 
 
Study Protocol and Statistical Analysis Plan for Research Project:  
 
“Emergence Agitation in Pediatrics after Dexmedetomidine vs. 
Sevoflurane Anesthesia: a randomized controlled trial” 
 
 
Clinicaltrials.gov # NCT06482125 
 
 
Conducted by Corry Quando Yahya, MD, Hori Hariyanto MD, PhD, Kohar Hari 
Santoso MD, PhD, Lucky Andriyanto MD, Arie Utariani MD, PhD, Bambang Pujo 
Semedi MD, PhD, Elizeus Hanindito MD, PhD 
July 1, 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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1. 
ABSTRACT 
BACKGROUND 
Emergence Agitation (EA) is a common occurrence in pediatric 
anesthesia. (1) The incidence has been reported to vary from 10% to 
as high as 80% after being exposed to inhalation anesthesia, 
particularly Sevoflurane. Maladaptive behaviors such as kicking, 
screaming, and thrashing are seen during agitation and contributes to 
postoperative complications such as tongue edema, re-bleeding of 
surgical wounds, falling out of bed, accidental removal of the 
intravenous line, bronchospasm and wound dehiscence. Anesthesia 
using Sevoflurane remain the main choice for cleft lip and cleft palate 
(CP) surgeries in children at the current moment. (1–3) As a result, 
majority of these children experience intense agitation after 
recovering from anesthesia.  
 
OBJECTIVES 
We propose a randomized controlled trial comparing emergence agitation 
in patients receiving Sevoflurane inhalation versus intravenous 
Dexmedetomidine infusion.  
 
Primary Hypotheses: 
The use of intravenous Dexmedetomidine reduces emergence agitation to 
children after anesthesia. 
 
METHODS 
All children enrolled to undergo an elective cleft lip or palate surgery at 
Pelita Harapan University and Siloam Hospital Lippo Village who fulfill 
the inclusion criteria will be selected. 
 
2. SPECIFIC AIMS 
 
Aim #1. To measure and compare emergence agitation between 
Sevoflurane and Dexmedetomidine group.  
Aim #2. To measure and compare time to extubation between 
Sevoflurane and Dexmedetomidine group. 
Aim #3: To measure and compare time to full recovery between 
Sevoflurane and Dexmedetomidine group. 
Aim #4: Report any adverse events or side effects in both groups.  
 
3. STUDY DESIGN 
• A randomized controlled trial, single-blinded. 
• Allocation: Simple Randomized (1:1) Patients are selected randomly 
using a computer-generated device to become a control arm 
(Sevoflurane) or treatment arm (Dexmedetomidine) 

 
 
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• Number of Arms: 2 (Sevoflurane vs. Dexmedetomidine) 
• Masking: Single (Participant) 
 
4. STUDY POPULATION 
Children ages 3 months to 120 months (10 years) scheduled for an 
elective cleft lip or palate surgery in Pelita Harapan University and 
Siloam Hospital Village, Tangerang, Indonesia. 
 
5. ELIGIBILITY TO PARTICIPATE ON THE STUDY 
 
Minimum Age: 
 
 3 months   
Maximum Age: 
 
 10 years   
Sex:  
 
 
All   
Gender Based: 
 
No   
Accepts Healthy Volunteers: Yes   
 
Criteria: 
 
Inclusion Criteria: 
➢ Patients with weight ranging 5 kg - 25 kg 
➢ Patients with American Society of Anesthesiologist (ASA) 
Physical Status Classification 1 and 2 
Exclusion Criteria: 
➢ Patients with any acquired congenital syndrome 
➢ Patients who are actively taking anti-seizure medications and/or 
has been diagnosed with epilepsy 
➢ Patients with functional and structural abnormalities of the heart, 
including arrythmias 
➢ Patients with liver disease 
 
6. RECRUITMENT 
All children admitted to undergo an elective cleft lip or palate surgery 
between July 31, 2024 up to December 1, 2024. 
 
7. DATA COLLECTION AND MEASURES 
Data will be measured and collected starting July 31, 2024 up to 
December 1, 2024.  
 
8. QUALITY ASSURANCE AND QUALITY CONTROL 
Preoperative assessment and randomization of group type was 
performed one day before the operation.  
 
 
9. RANDOMIZATION AND MASKING 
A computer-generated random array sealed and envelope 

 
 
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method was employed to divide enrolled pediatric patients into two 
groups 
by 
simple 
randomization 
(1:1 
ratio 
allocation). 
Experimental medication was prepared and provided by research 
staff who were not directly involved in patient care, while the 
surgeon, anesthesiologist and participating families were blinded 
to the medication distribution and group allocation.  
On the day of surgery, the anesthesiologist responsible of the 
case was informed on each child’s allocation and gave medications 
according to their designated groups. Agitation scale upon 
awakening and extubation time were recorded by a nurse anesthetist 
inside the operating room; while agitation monitoring every fifteen 
minutes were carried out by a different nurse in the recovery room 
without prior knowledge of the child’s group allocation. 
 
10. 
INTERVENTIONS 
Anesthesia was administered using inhalation of 8% 
Sevoflurane in 100% oxygen until an intravenous line was secured. 
All patients were given Fentanyl 2 micrograms/kg, Propofol 
3mg/kg and an oral endotracheal intubation of appropriate size was 
secured. After intubation, patients in Group DEX stopped receiving 
Sevoflurane. Dexmedetomidine infusion using an intravenous line 
was started at a loading dose of 1.5ug/kg for 10 minutes, followed 
by a maintenance dose of 1.5ug/kg/hour via a syringe pump while 
patients in Group SEVO continued receiving Sevoflurane at a 
concentration of 2-3 vol%.  
All patients maintained spontaneous ventilation throughout the 
intraoperative period. Analgesia was supplemented with local 
anesthetic infiltration at the surgical site and intravenous 
Paracetamol 15mg/kg given 10 minutes before the end of surgical 
procedure. At the end of surgery, Dexmedetomidine infusion was 
stopped in group DEX and Sevoflurane inhalation was stopped in 
group SEVO: every one of them was extubated and moved to the 
post-anesthesia care unit for postoperative monitoring. 
 
 
 
 

 
 
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Fig 1. Flowchart of patient selection and grouping 
 
11. 
SAFETY MONITORING 
➢ Potential risks : bradycardia, hypotension, hypertension 
➢ Alert values: Patients are continually monitored using standard 
monitoring which includes an electrocardiograph (ECG), non-
invasive blood pressure and peripheral oxygen saturation 
(SpO2) which were recorded starting from induction and every 
5 min, thereafter. Monitoring of anesthestic depth was ensured 
using SEDLine™ monitor, Masimo Corporation, Irvine, CA, 
USA to measure processed electroencephalograph or Patient 
State Index (PSI). Throughout the procedure, all patients 
retained their spontaneous respiration while maintaining their 
PSI value between 25-50. 
➢ Reporting Procedures: written on a paper during research. 

 
 
6 
 
Preoperative 
anxiety 
status 
will 
be 
assessed 
by 
an 
anesthesiologist, the day before surgery. Time to extubation and 
agitation scale upon awakening will be recorded by the nurse 
anesthetist assisting the anesthesiologist on the day of operation. 
After transferring the child to the recovery room, another nurse 
will assess their agitation scale every 15 minutes using Cravero 
agitation scale. All these values are inputted on a computer after 
completion of anesthesia procedure, at the end of the day by a 
research staff who is not involved in patient care. 
 
12. STATISTICAL POWER AND SAMPLE SIZE 
ESTIMATION 
 
This study compares the incidence of agitation between the Sevoflurane 
group and the Dexmedetomidine group. This study is a categorical data, 
so the sample formula uses the formula: 
 
 
 
 
Dexmedetomidine (p1) versus Sevoflurane (p2) anesthesia were 
analyzed with p1 being 10% and p2 being 40% with a power of 0.8 and 
alpha of 0.05. The power analysis study yielded sample size of 35 
patients in each group. Considering 20% dropout case, we needed 42 
cases per group and a total of 84 cases. Results were expressed as range 
(median), mean ± standard deviation, or number (%). 
 
13. ANALYSIS PLAN 
Missing and Incomplete data will be reported, if there are any. 
 
14. DATA MANAGEMENT 
Data confidentiality is ensured as all data are secured and locked in our 
institution. Access is only granted to the researchers involved. 
 
15. TRIAL ADMINISTRATION -  HOW INVESTIGATORS/STAFF 
WILL BE ORGANIZED 
➢ The surgeon, anesthesiologist and participating families were blinded 
to the medication distribution and group allocation.  
➢ After preoperative assessment and patient met the inclusion criteria, 
patients or the patient’s family chose an envelope with a number inside 
it. The selected number later specified whether the patient was a control 
group or a treatment group, as randomized by the computer with 1:1 
ratio allocation. 

 
 
7 
 
➢ Experimental medication was prepared and provided by research staff 
who were not directly involved in patient care for use the following 
day that surgery took place. On the day of operation, the 
anaesthesiologist responsible in anesthetizing the child will be 
informed of the child’s group allocation in order to provide the 
appropriate medication according to their designated groups. The 
surgeon and recovery room nurse were not informed of the child’s 
group allocation. 
 
16. TIMELINE 
➢ Research data gathering will be performed starting July 31, 2024 up to 
December 31, 2024. 
➢ Data processing will start from January 1, 2025 to February 28, 2025. 
➢ Research writing is expected to be completed at July 1, 2025. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Appendix 1. Modified Yale Preoperative Anxiety Scale (mYPAS) 1 
  
SCORE 
Behavior 
1 
2 
3 
4 
5 
6 
Activity 
Looking around, curious, 
playing with toys, read 
ing (or other age-appropriate 
behavior); moves around  
holding area/treatment room to 
get toys or go to parent;  
may move toward OR 
equipment. 
Not exploring or 
playing, may look 
down, may f idget with 
hands or suck thumb 
(blanket); may sit close 
to parent while 
waiting, or play has a 
definite manic quality. 
Moving from toy to parent 
in unfocused manner, 
nonactivity-derived 
movements; 
frenetic/frenzied movement 
or play; squirming, moving 
on table, may push mask 
away, or clinging to parent. 
 Actively trying to get 
away, pushes with feet 
and arms, may move 
whole body; in waiting 
room, running around 
unfocused, not looking 
at toys or will not sepa 
rate from parent, 
desperate clinging. 
  
  
Vocalization 
Reading (nonvocalizing 
appropriate to activity), asking 
questions, making comments, 
babbling, laughing, readily 
answers questions but may be 
generally quiet; child too 
young to talk in social 
situations or too engrossed in 
play to respond. 
Responding to adults 
but whispers, “baby 
talk,” only head 
nodding. 
Quiet, no sounds or 
responses to adults. 
Whimpering, moaning, 
groaning, silently 
crying. 
Crying or 
may be 
screaming 
“no.” 
Crying, 
screaming 
loudly, 
sustained 
(audible  
through 
mask) 
Emotional 
Expressivity 
Manifestly happy, smiling, or 
concentrating on play. 
Neutral, no visible 
expression on face. 
Worried (sad) to 
frightened, sad, worried, or 
tearful  
eyes. 
Distressed, crying, 
extremely upset, may 
have wide eyes. 
  
  
State of 
apparent 
arousal 
Alert, looks around 
occasionally, notices or 
watches what anesthesiologist 
does with him/her (could be 
relaxed). 
Withdrawn, child 
sitting still and quiet, 
may be sucking on 
thumb or face turned 
into adult. 
Vigilant, looking quickly 
all around, may startle to 
sounds, eyes wide, body 
tensed. 
Panicked whimpering, 
may be crying or 
pushing others away, 
turns away 
  
  
 

Scoring produce 4 mYPAS scores (1 for each behaviour). Each score is calculated by dividing each item rating by the highest possible rating (i.e., 
6 for the “vocalizations” item and 4 for all other items), adding all the produced values, dividing by 4 and multiplying by 100. This calculation 
produces a score ranging from 23.33 to 100, with higher values indicating higher anxiety. In this study, the cutoff value of anxiety is taken from 
study by Eko et al2 which reported a score of 29 to be non-anxious children; while a mYPAS score of  ≥ 29 is considered as children who are 
anxious. 
Example 1: 
Activity = 1/4 = 0.25 
Vocalization = 1/6 = 0.16 
Emotional Expressivity = 1/4 = 0.25 
State of apparent arousal = 1/4 = 0.25 
Total points = (0.25 + 0.16 + 0.25 + 0.25) / 4 = 0.2275 
Multiply by 100 = 0.2275 x 100 = 22.75% 
 
Example 2: 
Activity = ¾ = 0.75 
Vocalization = 3/6 = 0.5 
Emotional Expressivity = 2/4 = 0.5 
State of apparent arousal = 2/4 = 0.5 
Total points = (0.75 + 0.5 + 0.5 + 0.5) / 4 = 0.56 
Multiply by 100 = 0.56 x 100 = 56% 
 
 
 
 
 
 
 
 
 
 
 

Appendix 2. CRAVERO SCALE 3 
 
Measurements are taken starting from extubation and repeated every 15 minutes until patient regain full consciousness or completely awakened. 
 
For example: 
Cravero Scale at extubation = 3 (at the operating theatre) 
At the recovery room area: 
Cravero Scale at 15 min = 4  
Cravero Scale at 30 min = 4 
Cravero Scale at 45 min = 4 
Cravero Scale at 60 min = patient awakened 
Hence, the average Cravero scale is (3+4+4+4)/4 = 3.75 (Classified as agitated) 
Time to complete awakening is 60 minutes. 
 
 
1. Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 
Sep;119(3):643-650. doi: 10.1213/ANE.0000000000000350. PMID: 25010821. 
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Scale 
Behaviour 
1 
Obtunded with no response to stimulation 
2 
Asleep, but responsive to movement and/or stimulation 
3 
Awake and responsive 
4 
Uncosolable crying more than 3 minutes, without any combative 
behaviour 
5 
Unconsolable with thrashing and combative behavior such as kicking, 
pushing, arching back and/or pulling intravenous lines 
A scale of 1.0-3.0 = not agitated; Scale > 3.1-5.0 = agitated