| CTRI Number |
CTRI/2023/06/054139 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
17/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of analgesic effect of dexemedetomidine & ketamine with dexemedetomidine in mechanically ventilated patients |
|
Scientific Title of Study
|
A comparative study of analgesic effect of Dexmedetomidine & ketamine with dexmedetomidine in mechanically ventilated adult patient: A Randomised control trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Babaloo kumar Singh |
| Designation |
MD Resident first year |
| Affiliation |
Indira Gandhi institute of medical sciences |
| Address |
Department of Anaesthesiology,
1st floor, Ward block
IGIMS
Patna
BIHAR
800014
India |
| Phone |
08252631393 |
| Fax |
|
| Email |
bablu2k10skmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod kr Verma |
| Designation |
professor |
| Affiliation |
Indira Gandhi institute of medical sciences |
| Address |
Department of Anesthesiology and CCM, 1st floor, IGIMS
Patna
BIHAR
800014
India |
| Phone |
9473191825 |
| Fax |
|
| Email |
drvvinodv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod kr Verma |
| Designation |
professor |
| Affiliation |
Indira Gandhi institute of medical sciences |
| Address |
Department of Anesthesiology and CCM, 1st floor, IGIMS
Patna
BIHAR
800014
India |
| Phone |
9473191825 |
| Fax |
|
| Email |
drvvinodv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi institute of medical sciences sheikhpura patna |
|
|
Primary Sponsor
|
| Name |
Dr Babaloo Kumar Singh |
| Address |
Indira Gandhi institute of medical sciences sheikhpura patna |
| 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 Babaloo kumar Singh |
Indira Gandhi Institute of Medical Sciences, Patna |
Surgical ICU, Department of Anaesthesiology & CCM
Patna
BIHAR |
8252631393
bablu2k10skmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of ethics committee Igims |
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 |
| Intervention |
Group D |
Dexmedetomidine infusion (0.5 mcg/kg/hr) to achieve target sedation.
Time points 2,4,6,8,12,24 hour till extubation |
| Comparator Agent |
Group K |
Ketamine 0.5 mg/kg/hr and dexmedetomidine 0.5 mcg/kg/hr to achieve target sedation.
Time points 2,4,6,8,12,24 hour till extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of ASA physical status 1 and 2
2.Patients between 18-60 years of age of either sex
3.Patients undergoing major abdominal surgery shifted to the ICU for elective ventilation.
|
|
| ExclusionCriteria |
| Details |
1.Patients who were pregnant or nursing; or had abnormal laboratory test results, significant psychiatric, neurological, cardiovascular, renal, or hepatic diseases.
2.Patients on Neuromuscular blocking agents
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Dexmedetomidine with combination of ketamine & dexmedetomidine in analgesia for elective post-operative mechanical ventilation after major surgery Analgesia defined as BPS score 5. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sedation score (till extubation)
Time to Extubation
Duration of ICU stay
Side effect profiles
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
30/06/2023 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bablu2k10skmc@gmail.com].
- For how long will this data be available start date provided 31-05-2023 and end date provided 31-05-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The objective of this study is to evaluate dexmedetomidine in comparison to combination of ketamine and dexmedetomidine (KETODEX) in analgesia for elective post-operative mechanical ventilation after major surgery . We also want to compare time to extubation, duration of ICU stay, pain scores, side effect profiles, and patient satisfaction with the two regimens.
|