| 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
|
|
|
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
|
|
|
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. |