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CTRI Number  CTRI/2025/04/084484 [Registered on: 09/04/2025] Trial Registered Prospectively
Last Modified On: 02/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Prophylactic Phenylephrine in propofol induced hypotension in general anaesthesia  
Scientific Title of Study   To study The Efficacy Of Prophylactic Intravenous Phenylephrine In Propofol Induced Hypotension During Induction Of General Anaesthesia - A Randomized Clinical Trial. 
Trial Acronym  TO STUDY THE EFFICACY OF PROPHYLACTIC INTRAVENOUS PHENYLEPHRINE IN PROPOFOL INDUCED HYPOTENSION DURING INDUCTION OF GENERAL ANAESTHESIA- A RANDOMIZED CLINICAL TRIAL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sagar Harishchandra Pawar 
Designation  Junior Resident  
Affiliation  Shri B M Patil Medical College and Hospital 
Address  Department of Anaesthesia, 3rd floor, Shri B. M. Patil Medical College, Vijayapura

Bijapur
KARNATAKA
586103
India 
Phone  08421177010  
Fax    
Email  sagarpawar2101@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijaykumar T K 
Designation  Professor 
Affiliation  Shri B M Patil Medical College and Hospital 
Address  3rd Floor OT Complex, Department of Anaesthesialogy, Shri B M Patil Medical College and Hospital, BLDE Deemed to be University, Solapur Road, Vijayapura

Bijapur
KARNATAKA
586103
India 
Phone  09844095250  
Fax    
Email  Vijaykumar.tk@bldedu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Vijaykumar T K 
Designation  Professor 
Affiliation  Shri B M Patil Medical College and Hospital 
Address  3rd Floor OT Complex, Department of Anaesthesialogy, Shri B M Patil Medical College and Hospital, BLDE Deemed to be University, Solapur Road, Vijayapura

Bijapur
KARNATAKA
586103
India 
Phone  09844095250  
Fax    
Email  Vijaykumar.tk@bldedu.ac.in  
 
Source of Monetary or Material Support  
Shri B M Patil Medical College and Hospital, Vijayapura, Karnataka, India 586103 
 
Primary Sponsor  
Name  Shri B M Patil Medical College and Hospital  
Address  Bangaramma Sajjan Campus, Solapur Road, 586103, Vijayapura Karnataka, India. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijaykumar T K  Shri B M Patil Medical College and Hospital   Department of Anaesthesia, 3rd Floor, Shri B. M. Patil Medical College, Bangaramma Sajjan Campus, Solapur Road, Vijayapura 586103, Karnataka
Bijapur
KARNATAKA 		 09844095250

Vijaykumar.tk@bldedu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BLDE(DU)/IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  intravenous phenylephrine in prevention of propofol induced hypotension intraoperatively at the time of induction of general anaesthesia  The study group will receive IV phenylephrine 100 mcg before induction of anaesthesia. 
Comparator Agent  Routine Procedure  The control group will recieve normal saline before induction of anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients posted for surgery under general anesthesia with ASA Grade I & II. 
 
ExclusionCriteria 
Details  Patients with Ischemic heart diseases, Pheochromocytoma.
Patients with cardiac conduction block.
Patients with Uncontrolled hypertension.
Patients with BP more than 180/110 mm Hg after intubation.
• Patients with difficult intubation
• Patient with allergies to any drug 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of intravenous phenylephrine in prevention of intraoperative hypotension due to propofol at time of induction of general anaesthesia  Intra operative vitals checked at 15 minutes after induction. 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of these hemodynamic parameters in both groups for any statistical significance  Comparison of hemodynamic parameters in both group after 15 mins of induction of anaesthesia. 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="130" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/04/2025 
Date of Study Completion (India) 18/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sagarpawar2101@gmail.com].

  6. For how long will this data be available start date provided 27-04-2026 and end date provided 27-04-2087?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   A Randomized control study to study.
The Prophylactic use of Phenylephrine for propofol induced hypotension.
The purpose of this to study the effectiveness of intravenous phenylephrine in prevention of propofol induced hypotension intraoperatively at the time of induction of general anaesthesia.
Dr Sagar Pawar
Junior Resident,
Department Of Anaesthresiology,

Shri B M Patil Medical College and Hospital, Vijayapura, Karnataka, 586103

 
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