| CTRI Number |
CTRI/2022/11/046967 [Registered on: 01/11/2022] Trial Registered Prospectively |
| Last Modified On: |
17/11/2023 |
| 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
|
A study to compare different parameters following opioid (medications that decrease pain) free technique versus standard technique of general anesthesia (using opioids) for removal of gall bladder . |
|
Scientific Title of Study
|
A randomized comparative study to evaluate recovery profile and hemodynamics of opioid free anesthesia versus standard balanced anesthesia technique for laproscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Kapoor |
| Designation |
Professor |
| Affiliation |
UCMS and GTBH |
| Address |
Room no 731A 7th Floor OT Block Dept of Anaesthesiology UCMS
and GTB Hospital
North East
DELHI
110095
India |
| Phone |
9560678023 |
| Fax |
|
| Email |
rudoc@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Kapoor |
| Designation |
Professor |
| Affiliation |
UCMS and GTBH |
| Address |
Room no 731A 7th Floor OT Block Dept of Anaesthesiology UCMS
and GTB Hospital
DELHI
110095
India |
| Phone |
9560678023 |
| Fax |
|
| Email |
rudoc@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Robin P Thomas |
| Designation |
Post Graduate Student |
| Affiliation |
UCMS and GTBH |
| Address |
ICU 2nd floor Dept of Anaesthesiology UCMS and GTB Hospital
North East
DELHI
110095
India |
| Phone |
9039279817 |
| Fax |
|
| Email |
robinpthomas007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
UCMS and GTB Hospital |
| Address |
Dept of Anaesthesiology, Dilshad Garden New Delhi 110095 |
| 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 Ruchi Kapoor |
UCMS and GTB Hospital |
Room no 731A 7th
Floor OT Block Dept of
Anaesthesiology UCMS
and GTB Hospital
North East
DELHI |
9560678023
rudoc@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| nstitutional Ethics Committee- Human Resources |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80||Cholelithiasis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Opioid free anesthesia(OFA) Group - Injection ketamine(bolus) followed by dexmedetomidine infusion |
Injection Ketamine 0.5 mg/kg at the time of induction of anesthesia and after creation of pneumoperitoneum dexmedetomidine infusion at the rate of 0.5ml/kg/hr (0.5 mcg/kg/hr) will be administered |
| Comparator Agent |
Standard balanced anesthesia (SBA) Group - Injection fentanyl (bolus) followed by saline infusion. |
Injection fentanyl 2 mcg/kg body weight at the time of induction of anesthesia and after creation of pneumoperitoneum Saline infusion 0.5 ml/kg/hr will be administered. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving consent for the study and aged 20-55 years belonging to ASA grade I or II scheduled for elective laparoscopic cholecystectomy under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
1. Patients with known case of cardiovascular, pulmonary, psychological or neurological diseases
2. Patients who are known to be epileptic
3. Patients who have signs and symptoms of raised intracranial tension
4. Patients with known allergies to the study drugs
5. Patients with abnormalities like heart block, left bundle branch block
6. Obese patients (BMI ≥ 30kg/m2)
|
|
|
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 |
| The time taken for extubation between the opioid free anesthesia versus standard balanced anesthesia group |
The time to extubation, which is the time taken from the injection of reversal to the extubation of endotracheal tube which will be counted in minutes (the same has been used for sample size calculation as well). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare between the two groups-
1. Hemodynamic parameters at the time of inubation
2. Hemodynamic parameters intraoperatively
3. Hemodynamic parameters at the time of extubation
4. Post-operative recovery using modified Aldrete score (Anexure III)
5. Post-operative pain using Numeric Rating Scale (NRS) (Anexure IV)
6. Total dose of rescue analgesia required in 24 hours
7. Any adverse effects
8. To assess the quality of post operative pain using QoR-15 score
|
24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
07/11/2022 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to compare Standard Balanced Anesthesia versus Opioid Free Anesthesia technique in laproscopic cholecystectomy. The Primary objective is comparison of time to extubation in patient of 2 groups. In the past there are studies comparing the two technique , however no study is directly related to our primary objective. The patients will be classified into OFA group who will receive Injection Ketamine (bolus) followed by dexmedetomidine infusion & SBA group who will receive Injection Fentanyl (bolus) followed by saline infusion. Further time to extubation & recovery profile of 2 groups will be compared |