| CTRI Number |
CTRI/2024/04/065195 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An act of comparing of three anesthetic drugs that is Dexmedetomidine- Ketamine- Propofol together compared with two drug group which is Ketamine-Propofol together for recovery quality |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine-Ketamine-Propofol combination versus Ketamine-Propofol combination for recovery characteristics in gynecological procedure: A randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Girish Vadhel |
| Designation |
Junior Resident |
| Affiliation |
Baroda Medical College |
| Address |
Department of Anesthesiology, Baroda Medical College, Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
8460458411 |
| Fax |
|
| Email |
girishvadhel05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha shah |
| Designation |
Assistant Professor |
| Affiliation |
Baroda Medical College |
| Address |
Department of anesthesiology
Baroda Medical College, Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9898019910 |
| Fax |
|
| Email |
nehakinitshah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha shah |
| Designation |
Assistant Professor |
| Affiliation |
Baroda Medical College |
| Address |
Department of anesthesiology
Baroda Medical College, Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9898019910 |
| Fax |
|
| Email |
nehakinitshah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, Baroda medical college, Vadodara |
|
|
Primary Sponsor
|
| Name |
Baroda Medical College |
| Address |
Department of Anesthesiology, Baroda Medical College, Baroda |
| 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 |
| Girish Vadhel |
SSG Hospital |
Gynecological operation theatre
Vadodara
GUJARAT |
8460458411
girishvadhel05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for Biomedical and Health Research (IECBHR) Medical College & SSG Hospital, Baroda |
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 DKP: Inj. Dexmedetomidine + Inj. Ketamine-Propofol |
1 microgram/kg dexmedetomidine diluted to 20 ml and will be given intravenously as bolus over period of 10 minute before administration of Inj. ketamine-propofol.
ketamine propofol mixture will be diluted in 20 ml syringe in which 5 mg/ml ketamine and 5 mg/ml propofol (1:1 mixture) will be given intravenously, slowly(10mg/second) in a dose of 0.8 mg/kg till UMSS score of 3 achieved.
Additional intravenous Ketamine-propofol will be given in 10 mg increments if the responsiveness to verbal commands is not lost within 60 seconds after drug administration. Then surgeon will be allowed for procedure.
Maintenance of sedation during procedure will be done by incremental dose of 10mg Ketofol when patient will do excessive tongue movement, coughing or body movements.
|
| Comparator Agent |
Group KP: Inj. Ketamine-propofol only |
20 ml of normal saline (NS) will be given intravenously first as bolus over period of 10 minutes before administration of inj. Ketamine-propofol.
ketamine propofol mixture will be diluted in 20 ml syringe in which 5 mg/ml ketamine and 5 mg/ml propofol (1:1 mixture) will be given intravenously, slowly(10mg/second) in a dose of 0.8 mg/kg till UMSS score of 3 achieved. Additional intravenous Ketamine-propofol will be given in 10 mg increments if the responsiveness to verbal commands is not lost within 60 seconds after drug administration. Then surgeon will be allowed for procedure. Maintenance of sedation during procedure will be done by incremental dose of 10mg Ketofol when patient will do excessive tongue movement, coughing or body movements. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.patients posted for gynaecological procedure having procedure time less than 30 minutes
2.ASA I, II, III
3.age/ sex 18-65 years, female
4.BMI less than 30kg/ m2
5.patient belonging to mallamppati grading I- II on airway assessment |
|
| ExclusionCriteria |
| Details |
1. Inability or refusal to follow the study protocol
2. Patient with uncontrolled medical conditions like hypertension, diabetes mellitus, renal failure, active seizure, raised intracranial pressure etc.
3. Patient with sever cardiovascular or pulmonary pathology, sever renal or liver disorders.
4. Patient having neuro psychiatric disorders, H/o drug or alcohol abuse etc.
|
|
|
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 |
To compare post procedure recovery characteristics for:
a)Recovery time (Time to achieve University of Michigan sedation scale 1 (UMSS 1))
b)Post procedure Emergence agitation: yes/no
c)Over all patient satisfaction score |
At end of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To monitor stability by monitoring systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse rate, peripheral oxygen saturation during procedure & maintain them within 20% of baseline value
2.To record total requirement of incremental dose of ketamine-propofol during procedure
3.Peri-procedure adverse events
4.Post procedure discharge time will be observed |
From baseline till end of procedure |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 4 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Moderate sedation is required for various short procedure such as endoscopy, gynaecological
procedure, ECT, fracture reduction, incision and drainage, debridement etc. to
ease discomfort while intervention with minimization of recovery agitations in
variety of patients. ASA 1,2 and 3 undergoing gynaecological procedure of age between 18 to 65 years with BMI < 30 kg/m^2 will be randomized to receive Dexmedetomidine-ketamine-propofol (n=32) or Ketamine-propofol (n=32) to compare recovery profile. The aim of this study was to evaluate and compare
the ketamine-propofol with and without dexmedetomidine for post procedure
recovery characteristics in patients undergoing gynaecological procedures. |