FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094514 [Registered on: 10/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing two anesthesia drug combinations (ketamine–propofol and dexmedetomidine–propofol) to see their effects on blood pressure and heart rate during insertion of a breathing device in patients undergoing surgery. 
Scientific Title of Study   comparison of hemodynamic profile during insertion of I gel using ketamine propofol and dexmedetomidine propofol in short general anaesthesia procedure A randamized controlled study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  s jayasri 
Designation  post graduate 
Affiliation  Sri manakula vinayagar Medical College and Hospital Kalitheerthalkuppam,Puducherry 605107 
Address  room no 106,Department of anaesthesiology,Sri manakula vinayagar Medical College and Hospital Kalitheerthalkuppam,Puducherry

Pondicherry
PONDICHERRY
605107
India 
Phone  7200290322  
Fax    
Email  jayasrisiva94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suneeth P Lazarus 
Designation  Proferssor,Head of the department 
Affiliation  Sri manakula vinayagar Medical College and Hospital Kalitheerthalkuppam,Puducherry 605107 
Address  room no 104,Department of anaesthesiology,Sri manakula vinayagar Medical College and Hospital Kalitheerthalkuppam,Puducherry

Pondicherry
PONDICHERRY
605107
India 
Phone  9894332543  
Fax    
Email  Lazarus.suneeth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suneeth P Lazarus 
Designation  Proferssor,Head of the department 
Affiliation  Sri manakula vinayagar Medical College and Hospital Kalitheerthalkuppam,Puducherry 605107 
Address  room no 104,Department of anaesthesiology,Sri manakula vinayagar Medical College and Hospital Kalitheerthalkuppam,Puducherry


PONDICHERRY
605107
India 
Phone  9894332543  
Fax    
Email  Lazarus.suneeth@gmail.com  
 
Source of Monetary or Material Support  
Sri manakula vinayagar Medical College and Hospital Kalitheerthalkuppam,Puducherry 605107 
 
Primary Sponsor  
Name  S jayasri 
Address  room no 106 Department of Anaesthesiology,Sri manakula vinayagar Medical College and Hospital Kalitheerthalkuppam,Puducherry 605107 
Type of Sponsor  Other [self] 
 
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 S jayasri  Sri manakula vinayagar Medical College   Room nov106,Sri manakula vinayagar Medical College and Hospital Kalitheerthalkuppam,Puducherry 605107
Pondicherry
PONDICHERRY 
7200290322

jayasrisiva94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMVMCH-ethicscommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dexmeditomidine-propofol   dexmeditomidine is given 1mcg/kg in 10 ml normal saline after 60 seconds propofol 1.5mg/kg given and the supra glottic device is inserted and the ease of insertion is assessed and the hemodynamic changes are recorded. 
Comparator Agent  ketamine -propofol  ketamine is given 1mg/kg after 60 seconds propofol 1.5mg/kg given and the supra glottic device is inserted and the ease of insertion is assessed and the hemodynamic changes are recorded 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patient undergoing short elective surgical procedure
patient of ASA physical status I and II
 
 
ExclusionCriteria 
Details  Anticipated difficult airway
History of hypersensitivity to any study drug
psychiatric disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Hemodynamic parameters and
ease of supra glottic airway device 
Hemodynamic parameters base line 1 min,3 min,5 min,10 mins after insertion 
 
Secondary Outcome  
Outcome  TimePoints 
Aldrete score   1 min and 10 min after procedure done 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   29/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/09/2025 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  jayasrisiva94@gmail.com

  6. For how long will this data be available start date provided 30-12-2026 and end date provided 18-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
Supraglottic airway devices like the i-gel are increasingly used during short general anaesthesia procedures due to their ease of insertion and reduced hemodynamic disturbance compared to traditional intubation. Propofol, a commonly used induction agent, requires higher doses for effective i-gel placement, potentially leading to hypotension and respiratory depression. To counter this, co-induction with either ketamine or dexmedetomidine has been explored. This study aims to compare the effectiveness and safety of ketamine-propofol versus dexmedetomidine-propofol combinations, focusing on hemodynamic changes, ease of insertion, and recovery profiles.

The study is a prospective, randomized, single-blinded clinical trial involving 78 adult patients undergoing elective short surgical procedures. Patients were divided into two groups: Group A received ketamine (1 mg/kg) with propofol (1.5 mg/kg), and Group B received dexmedetomidine (1 µg/kg over 10 minutes) with propofol (1.5 mg/kg). Standard premedication was administered, and insertion of the i-gel was performed following a negative trapezius squeeze test. Variables assessed included jaw relaxation, insertion conditions, hemodynamic parameters, time taken for insertion, number of attempts, need for additional propofol, and Aldrete recovery scores.

The primary outcomes focus on comparing heart rate, blood pressure, and oxygen saturation between the two groups, while secondary outcomes include insertion ease, propofol requirement, adverse events, and post-operative recovery scores. The study is expected to clarify which co-induction combination better maintains hemodynamic stability and facilitates smoother i-gel insertion. The findings could guide anaesthetic practices in selecting the optimal sedative combination for safer and more efficient airway management in short-duration surgeries.
 
Close