| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - jayasrisiva94@gmail.com
- 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.
- 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. |