| CTRI Number |
CTRI/2020/10/028305 [Registered on: 08/10/2020] Trial Registered Prospectively |
| Last Modified On: |
28/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two new methods of providing anesthesia for patients undergoing operation without use of opioid medication. |
|
Scientific Title of Study
|
A randomised controlled double blind study to compare ketamine-dexmedetomidine versus ketamine-propofol combinations for opioid free anaesthesia in patients undergoing brachial plexus injury repair. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Veparala prudhvi raj |
| Designation |
MBBS |
| Affiliation |
PGIMER |
| Address |
House no 67,second floor ,garg house, sector 15 A, Chandigarh, Chandigarh, india
Sector 12, Chandigarh,
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9500918238 |
| Fax |
|
| Email |
prudhvipersonalmail@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas saini |
| Designation |
Additional professor |
| Affiliation |
PGIMER |
| Address |
Office rooms, second floor, nehru hospital, PGIMER, Chandigarh, India
Sector 12, Chandigarh,
Chandigarh
CHANDIGARH
160015
India |
| Phone |
7087008119 |
| Fax |
|
| Email |
drvsaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Veparala prudhvi raj |
| Designation |
MBBS |
| Affiliation |
PGIMER |
| Address |
Room no 3, House no 67, sector 15 A, Chandigarh, Chandigarh, india
Fourth floor, anesthesia office Sector 12, Chandigarh,
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9500918238 |
| Fax |
|
| Email |
prudhvipersonalmail@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER, sector 12, Chandigarh |
|
|
Primary Sponsor
|
| Name |
No sponsor |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 PRUDHVI RAJ |
PGIMER |
MAIN OPERATION THEATRE, NEHRU hospital, department of anesthesia and intensive care, PGIMER, SECTOR 12 , CHANDIGARH, INDIA
Chandigarh
CHANDIGARH |
9500918238
Prudhvipersonalmail@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee PGIMER, chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G540||Brachial plexus disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Induction:intravenous dexmedetomidine 1 mcg/kg over 10 minutes slow infusion at beginning of anesthesia
Maintainance: intravenous dexmedetomidine 0.5 mcg/kg/hr throughout the surgery duration |
| Comparator Agent |
Propofol |
Induction: intravenous Propofol 1-2 mg/kg bolus
Maintainance: intravenous propofol 100mcg/kg/min continuous infusion through surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Undergoing brachial plexus injury repair under general anesthesia
ASA I or II |
|
| ExclusionCriteria |
| Details |
High risk coronary or vascular disease
Patient on beta blockers
Hepatic dysfunction
Eye globe injuries
Increased intracranial pressure
Increased intraocular pressure
History of psychosis
Uncontrolled hypertension |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Requirement of additional analgesic intraoperatively |
Baseline and postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post-operative pain score |
15 min, 30 min, 1 hr, 2 hr, 4hr, 6 hr, 12 hr, 18 hr, 24hr |
| Time to first rescue analgesia |
Time to first dose |
| Post operative sedation level |
Post operative sedation level |
| Time to achieve modified Aldrete score 9 |
10 min, 20 min, 30 min, 40 min, 50 min, 60 min |
| Total analgesic requirement in first 24 hours |
First 24 hours |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
11/10/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In current anesthesia practice we use opioids as a crucial part to provide analgesia(pain relief) to the patient. Since ages we have known that opioids provide profound analgesia, yet they come with many side effects. This study is aimed to provide analgesia to the patients by non opioid medications, thereby excluding opioid side effects. This study compares two methods of delivering anesthesia to patients undergoing surgery in general anaesthesia while avoiding opioids, and the pain profile of patients during and after the surgery. |