| CTRI Number |
CTRI/2021/09/036612 [Registered on: 17/09/2021] Trial Registered Prospectively |
| Last Modified On: |
31/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The amount of Propofol required for induction of anesthesia when it is given at 1min /3min /5min after injection of fentanyl. |
|
Scientific Title of Study
|
A DOUBLE BLIND RANDOMIZED STUDY TO EVALUATE IF INCREASING THE TIME INTERVAL BETWEEN ADMINISTRATION OF FENTANYL AND PROPOFOL REDUCE THE INDUCTION DOSE OF PROPOFOL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1234567890 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mumthaz Hashim |
| Designation |
Post Graduate Student , Department of Anaesthesiology |
| Affiliation |
Karnataka Institute of Medical Sciences , Hubli, Karnataka |
| Address |
Room 206
Department Of Anesthesiology
Karnataka Institute of Medical Sciences
Hubli
Karnataka
Dharwad
KARNATAKA
580021
India |
| Phone |
7403256710 |
| Fax |
|
| Email |
mumthazhashim04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basavaraj Kallapur |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Room No:206
Department of Anesthesiology
Karnataka Institute of Medical Sciences
Hubli
Karnataka
Dharwad
KARNATAKA
580021
India |
| Phone |
8660486142 |
| Fax |
|
| Email |
doc_basu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basavaraj Kallapur |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Room No:206
Department of Anesthesiology
Karnataka Institute of Medical Sciences
Hubli
Karnataka
Dharwad
KARNATAKA
580021
India |
| Phone |
8660486142 |
| Fax |
|
| Email |
doc_basu@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of Medical Sciences, Hubli |
|
|
Primary Sponsor
|
| Name |
Mumthaz Hashim |
| Address |
Room 108
Sai Samrudhi Ladies PG
Vidyanagar
Hubli
Karnataka |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Basavaraj Kallapur |
Professor
Room No:206
Department of Anesthesiology
Karnataka Institute of Medical Sciences
Hubli
Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mumthaz Hashim |
Department of Anesthesiology |
Room No:206
Department of Anesthesiology
KIMS
Hubli
580021
Dharwad
KARNATAKA |
7403256710
mumthazhashim04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of medical Sciences, Hubli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (2) ICD-10 Condition: H65-H75||Diseases of middle ear and mastoid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Propofol after 1min of fentanyl |
Here patients will receive induction dose of propofol after 1min of fentanyl administration. |
| Intervention |
Propofol after 3 min of fentanyl |
Here patients will receive induction dose of propofol after 3min of fentanyl administration |
| Intervention |
Propofol after 5min of fentanyl |
Here patients will receive induction dose of propofol after 5min of fentanyl administration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anesthesiologists (ASA) physical status I and II
2. Patients undergoing any elective surgeries under General Anesthesia
3. Patients giving informed valid written consent |
|
| ExclusionCriteria |
| Details |
1. Patients refusing to give consent
2. Patients posted for emergency surgeries
3. Patients with anticipated or actual difficult airway
4. Patients with cardiac, renal, hepatic, cerebral diseases
5. Patients allergic to Propofol and / or fentanyl
6. Patients with BMI <18kg/m2 and > 30kg/m2
7. Patients with alcohol intake and drug (enzyme inducer) use
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the total dose of Propofol required for induction of anesthesia following administration of Fentanyl at varying time intervals. |
Dose of Propofol required will be measured at the end of 1min, 3min and 5min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of varying time intervals between administration of Fentanyl and Propofol on hemodynamic variables such as hear rate, Systolic BP, Diastolic BP and Mean Arterial Pressure. |
HR, SBP, DBP, MAP, spo2 measured every minute upto 10 minutes. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 1 |
|
Date of First Enrollment (India)
|
01/01/2022 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Propofol is the most commonly used intravenous induction agent. This is a randomized study to examine the effect of varying time intervals between Fentanyl and Propofol administration (1min, 3min, 5min intervals) on the dose of Propofol required for induction of anesthesia. |