| CTRI Number |
CTRI/2024/02/062339 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study to compare hemodynamic stability and analgesia in patients recieving Propofol -Fentanyl Vs Propofol -Ketamine combination |
|
Scientific Title of Study
|
Comparative study of Propofol -Ketamine Vs Propofol -Fentanyl combination for hemodynamic stability and analgesia in adult patients undergoing elective 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 |
Shaishabi Bhowmick |
| Designation |
PG Junior Resident |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot |
| Address |
Department of Anesthesiology
Guru Gobind Singh Medical College and Hospital, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
7837804676 |
| Fax |
|
| Email |
shaibhow@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarvjeet kaur |
| Designation |
Professor and head Department of Anesthesiology |
| Affiliation |
Guru Gobind Singh Medical College and Hospital |
| Address |
Department of Anesthesiology
Guru Gobind Singh Medical College and Hospital, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarvjeet kaur |
| Designation |
Professor and head Department of Anesthesiology |
| Affiliation |
Guru Gobind Singh Medical College and Hospital |
| Address |
Department of Anesthesiology
Guru Gobind Singh Medical College and Hospital, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Guru Gobind Singh Medical College and Hospital, Faridkot |
|
|
Primary Sponsor
|
| Name |
Guru Gobind Singh Medical College and Hospital Faridkot |
| Address |
Department of Anesthesiology, Guru Gobind Singh Medical College and Hospital, Faridkot |
| 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 Shaishabi Bhowmick |
Guru Gobind Singh Medical College and Hospital |
Department of Anesthesiology, Guru Gobind Singh Medical College and Hospital, Faridkot
Faridkot
PUNJAB |
7837804676
shaibhow@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of GGSMCH, Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Profol-Fentanyl |
To evaluate hemodynamic stability and analgesia in patients recieving Profol-Fentanyl combination in short surgical procedures of 30-60 minutes duration |
| Comparator Agent |
Propofol -Ketamine |
To evaluate hemodynamic stability and analgesia in patients recieving Propofol -Ketamine combination in short surgical procedures of 30-60 minutes duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients from 18-60years of age scheduled for elective surgeries of 30-90 mins duration and belonging to ASA Grade I and II |
|
| ExclusionCriteria |
| Details |
Patients who are hemodynamically unstable
History of anaphylaxis or allergy to the study drugs
Pregnant females
History of head injury or seizure disorders
Psychiatric illness or drug abuse
BMI more than equal to 30 kg per metre square |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare hemodynamic stability of Propofol-Fentanyl Vs Propofol -Ketamine combination in elective short surgical procedures |
To compare hemodynamic stability of Propofol-Fentanyl Vs Propofol -Ketamine combination in elective short surgical procedures of 30-90 minutes duration over a period of 1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare analgesia in patients recieving Profol-Fentanyl Vs Propofol -Ketamine combination in elective short surgical procedures of duration 30 to 60 minutes |
Outcome will be assessed at the end of one & half year of study |
|
|
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)
|
10/02/2024 |
| 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="1"
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
|
Introduction - Total Intravenous Anaesthesia (TIVA) has many advantages like minimal cardiac depression, decreased oxygen consumption, avoidance of post operative diffusion hypoxia and less incidence of post operative nausea and vomiting etc. Various studies are being done to find out an ideal agent for TIVA and in our study we are evaluating two drug combinations to find out the same.
Aims and Objectives- We aim to evaluate two drug combinations, Propofol -Fentanyl and Propofol -Ketamine for their induction, maintenance and recovery characteristics and to compare their hemodynamic stability and post operative analgesic effect.
Material and Methods- The study will be conducted in a comparative manner in GGS Medical College and Hospital, Faridkot on 60 patients belonging to American Society of Anesthesiologists (ASA) Grade I and II; aged between 18-60 years who are scheduled for elective short surgical procedures under total intravenous anaesthesia. Patients will be allocated into two groups of 30 each. Group F will receive 1.5mg/kg of Propofol and 2 mcg/kg of fentanyl for induction and 2mg/kg/hr of propofol and 2 mcg/kg/hr of fentanyl for maintenance of anaesthesia intravenously. Group K will receive 1.5mg/kg of propofol and 1mg/kg of ketamine for induction of anaesthesia and 2mg/kg/hr of ketamine for maintenance of anaesthesia intravenously. The patients will be observed for their intra operative and post operative hemodynamic changed followed by their post operative rescue analgesic requirement and any adverse effects for 24 hrs. The data will be then statically analysed. |