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CTRI Number  CTRI/2025/12/099001 [Registered on: 12/12/2025] Trial Registered Prospectively
Last Modified On: 12/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing standard anesthesia with an opioid-sparing technique to see which helps children recover faster after cleft palate surgery 
Scientific Title of Study   “Comparison of Opioid-Sparing Versus Conventional Opioid-Based Anaesthetic Technique on Recovery Characteristics in Paediatric Patients Undergoing Cleft Palate Repair – A Randomised Controlled Trial.” 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saurav Devale 
Designation  Junior resident 
Affiliation  All India Institute Of Medical Sciences 
Address  Department of Anaesthesiology, All India Institute of Medical Sciences, Rishikesh, Dehradun, Uttarakhand

Dehradun
UTTARANCHAL
249202
India 
Phone  7023887681  
Fax    
Email  devalesaurav612@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mridul Dhar 
Designation  Associate Professor 
Affiliation  All India Institute Of Medical Sciences 
Address  Department of Anaesthesiology, All India Institute Of Medical Sciences, Rishikesh, Dehradun , Uttarakhand

Dehradun
UTTARANCHAL
249202
India 
Phone  9717778374  
Fax    
Email  mriduldhar87@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Saurav Devale 
Designation  Junior resident 
Affiliation  All India Institute Of Medical Sciences 
Address  Department of Anaesthesiology, All India Institute of Medical Sciences, Rishikesh, Dehradun, Uttarakhand

Dehradun
UTTARANCHAL
249202
India 
Phone  7023887681  
Fax    
Email  devalesaurav612@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Rishikesh 
 
Primary Sponsor  
Name  AIl India Institue Of Medical Sciences Rishikesh 
Address  Department of Anaesthesiology, All India Institute of Medical Sciences, Rishikesh, Dehradun, Uttarakhand, 249202 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saurav Devale  All India Institute of Medical Sciences, Rishikesh  Department of Anaesthesia, A Block 5th floor.
Dehradun
UTTARANCHAL 		 7023887681

devalesaurav612@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, All India Institue of Medical Sciences, Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Opioid based anaesthesia for cleft palate repair surgery.  Use of Injection FENTANYL 1 to 1.5 mcg per kg intravenous bolus once followed by Injection PROPOFOL 2 to 3 mg per kg intravenous bolus once. For muscle relaxation Injection VECURONIUM 0.1 mg per kg intravenous bolus followed by 0.05 mg per kg intravenous maintenance dose which might be repeated for muscle relaxation. Total duration will be according to period of surgery , that is cleft palate repair.  
Intervention  Opioid sparing general anaesthesia for cleft palate repair  Use of Injection DEXMEDETOMIDINE 1 mcg per kg intravenous bolus once in preoperative period just before shifting to operation room. In operating room induction with Injection KETAMINE and Injection PROPOFOL in 1 to 1 ratio combination solution with dosing 0.5mcg per kg for each drug given intravenous once. Injection LIGNOCAINE 1.5 mg per kg intravenous once . For muscle relaxation Injection VECURONIUM 0.1 mg per kg intravenous bolus. All the above drugs dosing frequency is one except muscle relaxant which might be given for maintenance dose multiple times with dosing 0.05 mg per kg according to duration of surgery. 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  6.00 Year(s)
Gender  Both 
Details  ASA Physical Status I or II
Age: 6 months to 6 years
Sex – male and female.
Elective, cleft palate repair.
 
 
ExclusionCriteria 
Details  Developmental delay or prematurity
Allergy to dexmedetomidine, propofol or lignocaine.
Severe cardiac conduction abnormalities
Baseline bradycardia [HR less than 50]
Severe hypovolemia
Advanced heart block
Severe ventricular dysfunction
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The time to first successful oral intake [in mins]   In the post op period : From the time of arrival in the post-anaesthesia care unit [PACU] or recovery area.  
 
Secondary Outcome  
Outcome  TimePoints 
Time to Extubation [minutes]  the cessation of inhalational anaesthetic agent to successful tracheal extubation (when TOF ratio more than equal to 0.9) 
WATCHA Score   post-extubation at 10 mins duration 
Intraoperative Hemodynamic Stability [HR & BP]  every 5 min intraoperatively 
Postoperative Vomiting [POV] Episode  within the first 4–6 hours postoperatively 
FLACC Score [Pain Assessment]  be recorded at 0, 30, and 60 minutes postoperatively 
Time to First Rescue Analgesia [minutes]:  the time from arrival in PACU to the administration of first rescue analgesic  
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   23/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This randomized, double-blind controlled trial aims to compare an opioid-sparing anaesthetic technique with a conventional opioid-based technique in children aged 6 months to 6 years undergoing cleft palate repair. Opioid-based anaesthesia may delay recovery due to respiratory depression, sedation, nausea, and emergence agitation. Opioid-sparing strategies using dexmedetomidine, ketamine, lignocaine, and regional nerve blocks may improve recovery and reduce opioid-related side effects.

Eligible patients will be randomized into two groups. The opioid-based group will receive fentanyl-based anaesthesia, while the opioid-sparing group will receive dexmedetomidine, Ketofoll and lignocaine, along with ultrasound-guided suprazygomatic maxillary nerve block. All patients will undergo standard general anaesthesia and postoperative monitoring.

The primary outcome is the time to first successful oral intake after arrival in the post-anaesthesia care unit (PACU). Secondary outcomes include intraoperative haemodynamic stability, time to extubation, emergence agitation (WATCHA score), postoperative vomiting, FLACC pain scores, and time first to rescue analgesia.

A total of 64 participants (32 per group) will be enrolled. The study will help determine whether opioid-sparing anaesthesia leads to faster recovery and fewer postoperative complications in paediatric cleft palate surgery.

 
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