| CTRI Number |
CTRI/2019/06/019790 [Registered on: 20/06/2019] Trial Registered Prospectively |
| Last Modified On: |
08/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of two drug combinations of propofol-ketamine and propofol-fentanyl for total intravenous anaesthesia in short surgical procedures |
|
Scientific Title of Study
|
Comparative evaluation of propofol-ketamine and propofol-fentanyl for short surgical procedures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna Jayaraj |
| Designation |
Post graduate student |
| Affiliation |
Kalinga institute of medical sciences |
| Address |
Department of Anaesthesiology, kalinga institute of medical sciences, bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8547489033 |
| Fax |
|
| Email |
draparnajayaraj91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Panda |
| Designation |
Assistant professor |
| Affiliation |
Kalinga institute of medical sciences |
| Address |
Department of Anaesthesiology, kalinga institute of medical sciences, bhubaneshwar
Khordha
ORISSA
751024
India |
| Phone |
9439862335 |
| Fax |
|
| Email |
amritapanda1323@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Panda |
| Designation |
Assistant professor |
| Affiliation |
Kalinga institute of medical sciences |
| Address |
Department of Anaesthesiology, kalinga institute of medical sciences, bhubaneshwar
Kendrapara
ORISSA
751024
India |
| Phone |
9439862335 |
| Fax |
|
| Email |
amritapanda1323@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kalinga institute of medical sciences |
| Address |
Department of Anaesthesiology, kalinga institute of medical sciences |
| Type of Sponsor |
Private 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 Aparna Jayaraj |
Kalinga institute of medical sciences |
Department of anaesthesiology,PradyumnaBal memorial hospital, campus 5, KIIT university, patia, bhubaneswar.
Khordha
ORISSA |
8547489033
draparnajayaraj91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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 |
| Comparator Agent |
Propofol-fentanyl |
Comparison in terms of intra operative hemodynamics, post operative nausea vomiting. Depth of sedation, time for recovery and time to rescue analgesics |
| Intervention |
Propofol-ketamine |
Comparison in terms of intra operative hemodynamics, post operative nausea vomiting, depth of sedation, time for recovery and time to rescue analgesics. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA 1 and 2 posted for elective surgical procedures lasting for less than 60 minutes, not requiring a difficult airway. |
|
| ExclusionCriteria |
| Details |
Patients belonging to ASA 3 4
History of allergy to any particular drug used in the study
History of egg allergy
History of opioid or substance abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic and respiratory parameters in the intra operative period. |
To compare the hemodynamic and respiratory parameters in the intra operative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the incidence of post operative nausea vomiting, depth of sedation, time to discharge from the PACU, and total dose of study drugs used |
Every 15 min from shifting the patient to PACU , till discharge from PACU |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2019 |
| 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="6"
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)?
|
|
Brief Summary
|
In this study a combination of propofol with ketamine is compared with a combination of propofol with fentanyl in patients undergoing total intravenous anaesthesia for elective surgeries of less than 60 minutes duration. Hemodynamic parameters, time to recovery, depth of sedation, incidence of post operative nausea vomiting and time to rescue analgesics are compared |