| CTRI Number |
CTRI/2023/10/059009 [Registered on: 23/10/2023] Trial Registered Prospectively |
| Last Modified On: |
21/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Administration of low dose Ketamine and/or Dexmedetomidine for attenuation of post-operative pain following laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Intra-operative low dose Ketamine versus Dexmedetomidine for attenuation of acute post-operative pain following laparoscopic cholecystectomy: A randomized clinical trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonia Naorem |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Anesthesiology, Regional Institute of Medical Sciences, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
9436033667 |
| Fax |
|
| Email |
sonianaorem7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Laithangbam Pradipkumar Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Anesthesiology, Regional Institute of Medical Sciences, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
7005238251 |
| Fax |
|
| Email |
drlaithangba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Laithangbam Pradipkumar Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Anesthesiology, Regional Institute of Medical Sciences, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
7005238251 |
| Fax |
|
| Email |
drlaithangba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences, Imphal, Manipur |
|
|
Primary Sponsor
|
| Name |
Sonia Naorem |
| Address |
Regional Institute of Medical Sciences, Imphal |
| Type of Sponsor |
Other [Post Graduate Trainee] |
|
|
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 Sonia Naorem |
Regional Institute of Medical Sciences, Imphal |
Elective Surgery Operation Theatre Complex (OT 1-8), Department of Anesthesiology, Regional Institute of Medical Sciences, Imphal
Imphal West
MANIPUR |
9436033667
sonianaorem7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, Regional Institute of Medical Sciences, Imphal |
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 |
Intra-operative Inj 5ml Normal Saline |
Study participants will be randomized into four groups. Comparator group will receive Inj 5ml Normal Saline IV 20mins before the anticipated skin closure |
| Intervention |
Intra-operative low dose dexmedetomidine |
Group D will receive Inj Dexmedetomidine 0.25mcg/kg IV diluted in 5ml Normal Saline intra-operatively 20 mins before the anticipated skin closure |
| Intervention |
Intra-operative low dose ketamine |
Group K will receive Inj Ketamine 0.25mg/kg IV diluted in 5ml Normal Saline intra-operatively 20 mins before the anticipated skin closure |
| Intervention |
Intra-operative low dose ketamine and dexmedetomidine |
Group DK will receive a combination of Inj Dexmedetomidine 0.25mcg/kg and Inj Ketamine 0.25mg/kg IV diluted in 5ml Normal Saline intra-operatively 20 mins before the anticipated skin closure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex
2. Age group 18-60years
3. Patients of American Society of Anesthesiology (ASA) grade I and II
4. Undergoing elective laparoscopic Cholecystectomy |
|
| ExclusionCriteria |
| Details |
1. Conversion to open cholecystectomy
2. Patients included in another study
3. Patients with history of significant cardiovascular disease (eg MI within the past 6months) |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the post-operative rescue analgesic requirements in the first 24hours |
Outcome to be assessed at 24hours post-op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. The Sedative effects |
30min post-op
1hour post-op
2hour post-op
6hour post-op
12hour post-op
24hour post-op |
| 2. The time of first rescue analgesic request |
When the VAS score more than or equal to 4 |
| Other side effects like dizziness, nausea, vomiting |
Anytime within the first 24hours post-op |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
30/10/2023 |
| 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="0"
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 study "Intra-operative low dose Ketamine versus Dexmedetomidine for attenuation of post-operative pain following laparoscopic cholecystectomy: A randomized clinical trial" will be conducted in the Department of Anesthesiology, Regional Institute of Medical Sciences, Imphal. After obtaining ethical clearance and informed written consent, 60 patients of both sexes between the age groups of 18-60years with ASA I and II will be randomized into one of the four groups.
Group D will receive Inj Dexmedetomidine 0.25mcg/kg IV diluted in 5ml Normal Saline, Group K will receive Inj Ketamine 0.25mg/kg IV diluted in 5ml Normal Saline and Group DK will receive a combination of Inj Dexmedetomidine 0.25mcg/kg and Inj Ketamine 0.25mg/kg IV diluted in 5ml Normal Saline, all to be given intra-operatively 20 mins before the anticipated skin closure.
Post operatively, total dose of the rescue analgesics (Inj Diclofenac IM) given in the first 24hours post-op will be compared. Sedation score (Ramsay Sedation Score) will be recorded at 30mins, 1hour, 2hour, 6hour, 12hour and 24hour post-op. Time of first rescue analgesic request when VAS score ≥4 will be recorded. Any episode of nausea, vomiting, dizziness in the first 24hours post-op will be recorded
|