| CTRI Number |
CTRI/2024/06/068439 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two anaesthesia techniques for adults undergoing laparoscopic cholecystectomy |
|
Scientific Title of Study
|
COMPARISON OF CONVENTIONAL OPIOID BASED VERSUS OPIOID FREE ANAESTHESIA FOR THE QUALITY OF RECOVERY IN ADULT PATIENTS UNDERGOING LAPAROSCOPIC 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 |
Darshana V |
| Designation |
Postgraduate resident |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8072730133 |
| Fax |
|
| Email |
darshanahema@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suman Saini |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9891228793 |
| Fax |
|
| Email |
drsainisumannony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suman Saini |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9891228793 |
| Fax |
|
| Email |
drsainisumannony@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman mahavir medical college and Safdarjung hospital, Ansari nagar, New Delhi - 110049 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar, New Delhi - 110049 |
| 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 |
| Darshana V |
Vardhman Mahavir medical college and Safdarjung hospital |
Department of Anaesthesia and Intensive care,Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar, New Delhi - 110029
South
DELHI |
8072730133
darshanahema@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, VMMC and SJH |
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 |
| Comparator Agent |
Comparison of opioid based anaesthesia with an opioid free approach in laparoscopic cholecystectomy surgeries |
Adult patients undergoing laparoscopic cholecystectomy will be randomized into two groups. One group will receive opioid based anaesthesia and the other group will receive an opioid free anaesthesia |
| Intervention |
Opioid based anaesthesia |
Patients will receive Fentanyl at a dose of 2mcg/kg over 5 minutes. Patients will be preoxygenated and induced with intravenous Propofol 2-2.5mg/kg titrated to verbal response. Vecuronium 0.1mg/kg will then be given. PLMA of appropriate size will be inserted.
Anaesthesia will be maintained with oxygen,air,and sevoflurane with intermittent doses of Vecuronium when needed.
At the end of the surgery neuromuscular blockade will be reversed with 100% oxygen, Inj Glycopyrollate 0.01mg/kg and Inj Neostigmine 0.05mg/kg.
Patient will then be extubated after adequate reversal is achieved.
Our intervention will begin at the induction of anaesthesia and end at extubation |
| Intervention |
Opioid free anaesthesia technique |
Inj Dexmedetomidine - loading dose of 0.8 mcg/kg over 10 minutes followed by maintenance dose of 0.3-0.5 mcg/kg/hr which will be stopped at deflation of pneumoperitoneum.
USG guided Subcostal TAP block - 20 ml of 0.25% Bupivacaine, USG guided Bilateral rectus sheath block - 10 ml of 0.25% Bupivacaine on each side will be given post the induction of anaesthesia.
A Pre-incisional dose of Inj Ketamine at 0.5mg/kg followed by maintenance at 0.25mg/kg if there is intraoperative pain/tachycardia.
Patients will be preoxygenated and induced with intravenous Propofol 2-2.5mg/kg titrated to verbal response. Vecuronium 0.1mg/kg will then be given. PLMA of appropriate size will be inserted.
Anaesthesia will be maintained with oxygen,air,and sevoflurane with intermittent doses of Vecuronium when needed.At the end of the surgery neuromuscular blockade will be reversed with 100% oxygen, Inj Glycopyrollate 0.01mg/kg and Inj Neostigmine 0.05mg/kg.
Patient will be extubated after adequate reversal is achieved.
Our intervention will begin at the induction of anaesthesia and end at extubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
18-65 years belonging to American society of Anaesthesiologists (ASA) physical status I -II
scheduled to undergo elective laparoscopic cholecystectomy under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Anticipated difficult airway
2. High risk of aspiration
3. Chronic analgesic therapy
4. Local block site infection
5. Previous abdominal surgery and/or chances of converting to open surgery
6. BMI > 30 kg/ |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the quality of recovery at 6 hours after the surgery using the QoR-40 score in adult
patients undergoing laparoscopic cholecystectomy |
At 6 hours after the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative haemodynamic parameters |
During surgery |
| Emergence time |
After the surgery |
| Time to first rescue analgesia and total amount used |
In the post-operative period |
| Stress hormone levels |
At baseline and at 6 hours |
| Assess the quality of recovery using QoR-40 score |
after 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/06/2024 |
| 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
|
This is a comparative, interventional study comparing an opioid based anaesthesia versus and opioid free anaesthesia technique in laparoscopic cholecystectomy surgeries with the primary objective being the comparison of the quality of recovery at 6 hours post surgery and the secondary objectives being the comparison of haemodynamic parameters, emergence time, cortisol levels at baseline and at 6 hours post surgery and the QoR-40 score at 24 hrs. |