| CTRI Number |
CTRI/2021/07/034859 [Registered on: 14/07/2021] Trial Registered Prospectively |
| Last Modified On: |
09/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effects of Midazolam, Dexmedetomidine and Ketamine premedication on the recovery profile after anaesthesia |
|
Scientific Title of Study
|
Effect of midazolam, dexmedetomidine or ketamine premedication on the recovery profile after balanced anaesthesia: A randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Phindariiaki Wankhar |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Lamphelpat, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
8413078481 |
| Fax |
|
| Email |
phindi07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laithangbam Pradipkumar Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Lamphelpat, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
9862635503 |
| Fax |
|
| Email |
drlaithangba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laithangbam Pradipkumar Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Lamphelpat, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
9862635503 |
| Fax |
|
| Email |
drlaithangba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences, Imphal 795004, Manipur |
|
|
Primary Sponsor
|
| Name |
Dr Phindariiaki Wankhar |
| Address |
Post Graduate Trainee, Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal - 795004, Manipur |
| Type of Sponsor |
Other [Self] |
|
|
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 Phindariiaki Wankhar |
Regional Institute of Medical Sciences |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal 795004
Imphal West
MANIPUR |
8413078481
phindi07@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: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Dexmedetomidine |
0.05 mcg/kg of IV Dexmedetomidine given over 10 minutes before induction of anaesthesia with Propofol |
| Comparator Agent |
intravenous Ketamine |
0.25 mg/kg of IV Ketamine given over 10 minutes before induction of anaesthesia with Propofol. |
| Intervention |
Intravenous Midazolam |
0.04 mg/kg of IV Midazolam given over 10 minutes before induction of anaesthesia with Propofol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and II
Undergoing major surgeries of duration less than 3 hours. |
|
| ExclusionCriteria |
| Details |
1. Hepatic, renal, neurological, cardiovascular and respiratory illnesses
2. Allergy to any study drug
3. Anticipated difficult airway |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recovery profile after balanced anaesthesia |
1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A randomized double-blinded clinical trial to study the effects of 0.04 mg/kg of IV Midazolam, 0.05 mcg/kg of IV Dexmedetomidine and 0.25 mg/kg of IV Ketamine pre-medication in the recovery profile in 99 patients aged 18 to 60 years with ASA I and II undergoing major surgeries of less than 3 hours duration under balanced anaesthesia. The study will be conducted in the Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur. The study drug will be given over 10 minutes before induction with Propofol. Post- operatively, recovery profile will be assessed in terms of emergence time, recovery time based on Modified Aldrete Score, time to first rescue analgesia based on Visual Analogue Scale (VAS), any episode of nausea/vomiting during the first one hour, any episode of dreaming, awareness on questioning post- operatively. |