| CTRI Number |
CTRI/2023/07/055087 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
08/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exploring the Analgesic Efficacy of Ketamine- Dexmedetomidine (Ketodex) in Elective Laparoscopic
Cholecystectomy :A Prospective Randomised Double Blind Controlled Study |
|
Scientific Title of Study
|
To evaluate the analgesic efficacy of Ketamine -Dexmedetomidine (Ketodex)in elective laproscopic cholecystectomy - Prospective Randomized double blind control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr EKTA RANI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES SHEIKHPURA PATNA |
| Address |
DEPT.OF ANAETHESIA AND CRITICAL CARE MEDICINE ,INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES SHEIKHPURA PATNA
DEPT.OF ANAETHESIA AND CRITICAL CARE MEDICINE ,INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES SHEIKHPURA PATNA
Patna
BIHAR
800014
India |
| Phone |
7004111493 |
| Fax |
|
| Email |
rinkibuxar111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mumtaz Hussain |
| Designation |
Additional Professor, Department of anaesthesiology and CCM |
| Affiliation |
Indira Gandhi institute of medical sciences, Sheikhpura,Patna |
| Address |
Department of anaesthesiology and CCM, 1st floor,OT complex,Indira Gandhi institute of medical sciences,Sheikhpura,Patna
Department of anaesthesiology and CCM, 1st floor,OT complex,Indira Gandhi institute of medical sciences,Sheikhpura,Patna
Patna
BIHAR
800014
India |
| Phone |
8544413239 |
| Fax |
|
| Email |
drhussain72@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mumtaz Hussain |
| Designation |
Additional Professor, Department of anaesthesiology and CCM |
| Affiliation |
Indira Gandhi institute of medical sciences, Sheikhpura,Patna |
| Address |
Department of anaesthesiology and CCM, 1st floor,OT complex,Indira Gandhi institute of medical sciences,Sheikhpura,Patna
Department of anaesthesiology and CCM, 1st floor,OT complex,Indira Gandhi institute of medical sciences,Sheikhpura,Patna
Patna
BIHAR
800014
India |
| Phone |
8544413239 |
| Fax |
|
| Email |
drhussain72@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute Of Medical Sciences Patna |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical Sciences Patna |
| Address |
Indira Gandhi Institute of Medical Sciences Sheikhpura Patna 800014 |
| 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 EKTA RANI |
Indira Gandhi institute of medical sciences, Sheikhpura,Patna |
Department of anaesthesiology and CCM, 1st floor,OT complex,Indira Gandhi institute of medical sciences,Sheikhpura,Patna
Patna
BIHAR
800014
India
Patna
BIHAR |
7004111493
rinkibuxar111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of ethics committee Indira Gandhi Institute Of Medical Sciences patna |
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 |
Infusion of Ketamine(K) |
Group K will receive intravenous Ketamine 0.5 mg/kg in 10 ml normal saline over 10 minutes before skin incision |
| Intervention |
Ketamine-dexmedetomidine (KD)infusion vs Ketamine (K) infusion
|
Group KD Patients will be receive intravenous bolus inj Ketamine - dexmedetomidine (0.5 mg/kg + 0.5 mcg/kg) in 10 ml normal saline over 10 minutes before skin incision |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
AS A 1 & 2
Patients having no any co morbidities
Patients willing to participate in the trial |
|
| ExclusionCriteria |
| Details |
ASA 3 & 4
Patients having college morbidities
Patients not willing to participate in the trial |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual analogue scale at 0 minute,30 minutes.1hr,2 hr ,4 hr ,6 hr ,8 hr ,12 hr,and 24 hr
Time of first rescue analgesia (inj Tramadol )
Total does of rescue analgesia (Inj.Tramadol) |
Visual analogue scale at 0 minute,30 minutes.1hr,2 hr ,4 hr ,6 hr ,8 hr ,12 hr,and 24 hr
Time of first rescue analgesia (inj Tramadol )
Total does of rescue analgesia (Inj.Tramadol) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the side effects of adding ketamine & dexmedetomidine if any (nausea vomiting, & bradycardia). |
post-operatively |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
19/07/2023 |
| 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 Applicable |
| 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
|
Patients will be randomly divided into two Group based on computer generated random numbers. Before skin incision study drugs will be given by anaesthesiologist who will not participate in study. Group KD Patients will be received intravenous bolus inj. Ketamine -dexmedetomidine (0.5mg/kg +0.5microgram/kg) in 10 ml over 10 minutes before skin incision. Group K Patients will be received intravenous bolus ketamine (0.5mg/kg)in 10 ml over 10 minutes before skin incision . Postoperative pain will be assessed using visual analogue scale at 0 minutes,30 minutes,1hr, 2hr,4hr,6hr,8hr, 12hr and 24 hr. |