| CTRI Number |
CTRI/2025/09/094814 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effects of two different General anaesthesia agents in adult patients undergoing General anaesthesia with airway Mask |
|
Scientific Title of Study
|
A Cross Sectional Study Comparing the Effects of Sevoflurane and Desflurane in adults patients undergoing General Anesthesia with Laryngeal Mask Airway |
| Trial Acronym |
not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms A Jayaprabha |
| Designation |
BSc (AHS) |
| Affiliation |
BIHER university |
| Address |
Department of Anesthesiology Third Floor Sree Balaji Medical College CLC works road Chrompet Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
7305234877 |
| Fax |
|
| Email |
jayaprabha128@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Kala |
| Designation |
Professor of Anesthesiology |
| Affiliation |
BIHER university |
| Address |
Department of Anesthesiology First floor Sree Balaji Medical College CLC works road Chrompet Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9444680908 |
| Fax |
|
| Email |
kalamhn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Kala |
| Designation |
Professor of Anesthesiology |
| Affiliation |
BIHER university |
| Address |
Department of Anesthesiology First Floor Sree Balaji Medical College and Hospitals CLC Works Road Chrompet Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9444680908 |
| Fax |
|
| Email |
kalamhn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology Sree Balaji Medical College and Hospitals CLC works road Chrompet Chennai Tamil Nadu India 600044 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
Sree Balaji Medical College and Hospitals CLC works Road Chrompet Chennai Tamil Nadu India 600044 |
| Type of Sponsor |
Private 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 |
| Ms A Jayaprabha |
General surgery Operation Theatre complex III Floor |
Department of Anesthesiology Third Floor Sree Balaji Medical College and Hospitals CLC works Road Chrompet Chennai 600044
Chennai
TAMIL NADU |
07305234877
jayaprabha128@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School of Allied Health Sciences IHEC Sree Balaji Medical College and Hospitals Bharath Institute of Higher Education and Research |
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 |
Group A patients for GA with Sevoflorane anesthesia through inhalational route |
Thirty patients randomly selected by using a computer-generated random number for Group A will receive GA with a 1 to 1.5 MAC value of Sevoflurane from the time of LMA insertion to the completion of the surgical procedure. The duration of surgery and the total dose of Sevoflurane used will be documented. In addition to this, the patients intraoperative hemodynamic status, oxygen saturation will be assessed continuously and documented every 10 minutes till the end of the surgery, and recovery will be assessed based on the recovery score |
| Intervention |
Group B patients for GA with Desflurane anesthesia through inhalational route |
Thirty patients randomly selected by using a computer-generated random number for Group B will receive GA with a 1 to 1.5 MAC value of Desflurane from the time of LMA insertion to the completion of the surgical procedure. The duration of surgery and the total dose of Desflurane used will be documented. In addition to this, the patients intraoperative hemodynamic status, oxygen saturation will be assessed continuously and documented every 10 minutes till the end of the surgery, and recovery will be assessed based on the recovery score |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II
Patients scheduled for elective surgery under GA with LMA
Patient is willing to participate in the research |
|
| ExclusionCriteria |
| Details |
ASA physical status III and above
Pregnant patients, paediatric patients
Patient scheduled for emergency surgeries
Patient with a history of smoking, chronic alcoholism, drug abuse, and psychiatric disorder
Patient refusal |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe and compare group A and B regarding the total volume of the inhalational agent, namely Sevoflurane or Desflurane used, total dose of the analgesic drug requirement, intraoperative hemodynamic stability, oxygen saturation, postoperative recovery score, and postoperative side effects, if any, will be assessed and documented for comparison |
Before starting the procedure, the baseline parameters of vital signs, SpO2, Heart rate, blood pressure, ECG, and temperature will be assessed. After every 10 minutes till the end of the surgery duration of surgery post post-operative recovery score, and once the patient recovers from General anaesthesia, all these parameters will be assessed and compared between the two groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nausea, Vomiting, Sore throat |
Hourly for 4hrs then after 24hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/09/2025 |
| Date of Study Completion (India) |
30/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This research aims to evaluate and compare the clinical performance of two inhalational anaesthetic agents—sevoflurane and desflurane, in adult patients scheduled for elective surgical procedures under general anaesthesia (GA) using a laryngeal mask airway (LMA). The study will assess key perioperative parameters, including the duration of surgery, intraoperative Oxygen saturation, Haemodynamic stability based on heart rate, blood pressure, mean arterial pressure and postoperative recovery characteristics based on recovery score and side effects such as nausea, vomiting and delirium. The goal is to determine which agent offers superior outcomes in terms of anaesthetic efficiency, patient safety, and recovery quality.
|