| CTRI Number |
CTRI/2024/09/073406 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Combination of Ketamine-Propofol versus Fentanyl-Propofol in short surgeries |
|
Scientific Title of Study
|
Comparative Study of Propofol- Ketamine vs Propofol- Fentanyl as Procedural Sedation for Total Intravenous Anaesthesia in Adults Undergoing Short Surgical Procedures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashanthi Ballepu |
| Designation |
1st Year Anaesthesia Resident |
| Affiliation |
Pandit Deendayal Upadhyay Medical College |
| Address |
Pandit Deendhayal Upadhyayay Medical College
Civil Hospital Campus
Department of Anaesthesiology
Main OPD Building
OT floor 3
Rajkot
GUJARAT
360001
India |
| Phone |
7997776682 |
| Fax |
|
| Email |
prashanthiballepu1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Parmar |
| Designation |
Professor and Head of Department of Anaesthesiology |
| Affiliation |
Pandit Deendayal Upadhyay Government Medical College |
| Address |
PDU Medical College and Hospital
Department of Anaesthesiology
New OPD Building
Rajkot
GUJARAT
360001
India |
| Phone |
9898090220 |
| Fax |
|
| Email |
drvandanapithadia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Parmar |
| Designation |
Professor and Head of Department of Anaesthesiology |
| Affiliation |
Pandit Deendayal Upadhyay Government Medical College |
| Address |
PDU Medical College and Hospital
Department of Anaesthesiology
New OPD Building
Rajkot
GUJARAT
360001
India |
| Phone |
9898090220 |
| Fax |
|
| Email |
drvandanapithadia@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Pandit Deendhayal Upadhyay Medical College and Hospital
Rajkot, Gujarat
India
360001 |
|
|
Primary Sponsor
|
| Name |
Pandit Deendayal Upadhyay Government Medical College |
| Address |
Sadar Civil Hospital Campus, Rajkot, Gujarat
India,360001 |
| 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 |
| Dr Prashanthi Ballepu |
Pandit Deendayal Upadhyay Government Medical College |
Department of Anaesthesiology
Main OPD Building
OT Floor 3
Rajkot, Gujarat
360001
Rajkot
GUJARAT |
07997776682
prashanthiballepu1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| P.D.U. Medical College Institutional Ethics Committee (Human) |
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 |
Combination of Propofol and Ketamine versus Propofol and Fentanyl in TIVA |
Patients will be anaesthetized for short surgical procedures (less than 30 minutes) either under the the combination of Propofol and Ketamine or with Propofol and Fentanyl |
| Comparator Agent |
Propopofol- Ketamine versus Propofol- Fentanyl |
Comparision of the effects and duration of sedation of propofol- ketamine combination versus propofol- fentanyl combination in short surgical procedures (less than 30 minutes) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
- All patients with normal airway (MPG 1&2)
- Study subjects classified as American Society of Anesthesiologists (grade I or II)
- All subjects scheduled for elective operations requiring general anesthesia and duration of surgery less than 40mins) |
|
| ExclusionCriteria |
| Details |
- Emergency Surgeries
- Patients allergic to eggs or soyproducts
- Patients with known or unanticipated difficult intubations
- Those with heart rhythms other than sinus
- Those with known allergy to study drugs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Demographic Data (Age and Sex)
2) Intraoperative Monitoring of Hemodynamic Variability (Pulse Rate, SBP, DBP, Respiratory Rate, Spo2(%)
3) Intraoperative Sedation Level using BIS monitor
4) Post-Operative Ramsay Sedation Score
5) Time to Recovery (Modified Aldrete Score)
6) Post- operative Side Effects
|
Initially, after 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 1 hr, 2hr, 4hr, 8hr, 12hr, 16hr, 20hr, 24hr
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall patient satisfaction post-procedure |
Immediate post-operatively, 4hrs, 8hrs, 1whrs, 16hrs, 20hrs, 24hrs |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
23/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
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
|
In this study, we are planning to evaluate the two TIVA regimes that are commonly used in practice- ketamine- propofol (ketofol) and fentanyl-propofol (fentofol). Studies have proven the efficacy of these two regimes in sedoanalgesia. In earlier studies, continuous infusions of either ketofol or fentofol have been prepared. However, in this study either ketamine or fentanylbis used only during induction, and maintainence in both cases is only with propofol. Keeping the factor of continuous infusion of propofol common in both the studies, hemodynamic parameters and recovery states are compared. |