FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091469 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare recovery after gallbladder removal surgery using anaesthesia with or without opioids. 
Scientific Title of Study   Comparison of opioid-free anaesthesia versus opioid based anaesthesia for quality of recovery after laproscopic cholecystectomy 
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 Honey Jaiswal 
Designation  Postgraduate Junior Resident  
Affiliation  Government Medical College & Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9630939407  
Fax    
Email  honey.15.jaiswal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Honey Jaiswal 
Designation  Postgraduate Junior Resident  
Affiliation  Government Medical College & Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9630939407  
Fax    
Email  honey.15.jaiswal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jasveer Singh 
Designation  Professor 
Affiliation  Government Medical College & Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121664  
Fax    
Email  drjassy18@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32, Chandigarh, India, Pincode- 160030 
 
Primary Sponsor  
Name  Government Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32, Chandigarh, India, Pincode- 160030 
Type of Sponsor  Government medical college 
 
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 Honey Jaiswal  Government Medical College & Hospital, Chandigarh  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32
Chandigarh
CHANDIGARH 
09630939407

honey.15.jaiswal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (GMCH, Chandigarh)  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 
Intervention  Dexmedetomidine  Intravenous dexmedetomidine bolus of 1 mcg/kg (diluted to 20 ml normal saline) in infusion over 10min, followed by lidocaine bolus of 1.0 mg/kg (diluted to 5ml of normal saline). 
Comparator Agent  Fentanyl  Intravenous fentanyl bolus of 1.5 mcg/kg (diluted to 20 ml normal saline) in infusion over 10 min followed by normal saline bolus of 5 ml. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age between 18 years to 65 years.
2.Patients undergoing laparoscopic cholecystectomy.
3.American Society of Anaesthesiologists (ASA) Grade I and II.
4.Body Mass Index (BMI) more than 18 and less than 35 kg/m2.
 
 
ExclusionCriteria 
Details  1.Patients with coagulopathy and platelet disorders.
2.Contraindication or allergy to study drugs.
3.Pregnant and lactating women.
4.Severe cardiovascular, respiratory, neurological or metabolic disease.
5.Inability of the patient to understand the QoR -15 questionnaire.
6.Patients with baseline heart rate less than 60 beats/minute.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
comparison of postoperative quality of recovery score in patients receiving opioid based anaesthesia vs. opioid free anaesthesia in laproscopic cholecystectomy  24 hours post-operatively 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the post operative pain score  30 min, 1 hour, 2 hour, 6 hour, 24 hour after surgery 
To compare the postoperative Ramsay sedation score in post anaesthesia care unit  15 min, 30 min, 45 min, 1 hour after surgery 
To compare the time of discharge from post anaesthesia care unit to the ward  1 to 2 hour 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   11/08/2025 
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="6"
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    A total of 70 patients undergoing laproscopic cholecystectomy will be randomly allocated to two groups of 35 patients each using computer generated random number table and the allotted number will be secured in a coded opaque sealed envelope. The patients will be allocated to one of the following two groups: Group OFA (n=35): Patients will be given opioid-free anaesthesia. Group OBA (n=35): Patients will be given opioid-based anaesthesia. 

Procedure on the day of surgery: 
Patient will be shifted to the operation room. Monitoring of heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, continuous electrocardiogram, arterial oxygen saturation (Spo2) and end-tidal CO2 (EtCO2) will be done. All baseline parameters will be recorded.
Before the induction of anaesthesia, the patients in the OFA group will receive intravenous dexmedetomidine bolus of 1 mcg/kg (diluted to 20 ml normal saline) in infusion over 10min, followed by lidocaine bolus of 1.0 mg/kg (diluted to 5ml of normal saline). Patients in the OBA group will receive intravenous fentanyl bolus of 1.5 mcg/kg (diluted to 20 ml normal saline) in infusion over 10 min followed by normal saline bolus of 5 ml. 
During maintenance of anaesthesia, the OFA group will receive a continuous intravenous infusion of dexmedetomidine 0.3mcg/kg/hr (diluted to 50 ml of normal saline) and intravenous infusion of lidocaine 1.5mg/kg/h (diluted to 50 ml of normal saline) with sevoflurane (1% to 3%), whereas the OBA group will receive a continuous intravenous infusion of fentanyl 0.5 mcg/kg/hr (diluted to 50 ml of normal saline) and 50 ml of normal saline infusion as placebo with sevoflurane (1% to 3%). 
The pain will be evaluated by using VAS score at 30 min, 1 h, 2 h, 6 h and 24 h which will be evaluated both at rest and on coughing. Quality of recovery score will be assessed at 24 hours after surgery using 15 item QoR questionnaire. The Ramsay Sedation Score will be evaluated every 15 min till the discharge of the patient from PACU. Time from PACU discharge will be noted. 
Patient will be monitored continuously intra and post operatively and observations will be recorded in the prescribed proforma.
 
Close