CTRI

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CTRI Number

CTRI/2025/07/090508 [Registered on: 08/07/2025] Trial Registered Prospectively

Last Modified On:

04/07/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

To compare the incidence of post-operative nausea and vomiting in patients undergoing laparoscopic surgeries using Isoflurane inhalation and Propofol infusion

Scientific Title of Study

Comparative evaluation of Isoflurane inhalation and Propofol infusion for maintenance of anaesthesia on the incidence of post-operative nausea and vomiting in patients undergoing laparoscopic surgeries

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Ngaknunnem Vaiphei
Designation	Post-graduate Resident
Affiliation	Vardhman Mahavir Medical College and Safdarjung Hospital
Address	Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, 110029 South West DELHI 110029 India
Phone	09402773769
Fax
Email	babynem20@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Dharam Singh Meena MD
Designation	Director Professor
Affiliation	Vardhman Mahavir Medical College and Safdarjung Hospital
Address	Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, 110029 South West DELHI 110029 India
Phone	09910277129
Fax
Email	dharams_meena@yahoo.com

Details of Contact Person
Public Query

Name	Dr Dharam Singh Meena MD
Designation	Director Professor
Affiliation	Vardhman Mahavir Medical College and Safdarjung Hospital
Address	Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, 110029 South West DELHI 110029 India
Phone	09910277129
Fax
Email	dharams_meena@yahoo.com

Source of Monetary or Material Support

Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi, 110029, India

Primary Sponsor

Name	Vardhman Mahavir Medical College and Safdarjung Hospital
Address	Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, 110029
Type of Sponsor	Other [Government Medical College]

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 Ngaknunnem Vaiphei	Vardhman Mahavir Medical College and Safdarjung Hospital	Department of Anaesthesia and Intensive Care,Ground Floor, Main OT, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, 110029 South West DELHI	09402773769 babynem20@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Vardhman Mahavir Medical College and Safdarjung Hospital	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
Comparator Agent	Isoflurane inhalation	Patients undergoing laparoscopic surgeries will be given Isoflurane inhalation for maintenance of anaesthesia with duration of about 2 hours.
Intervention	Propofol infusion	Patients undergoing laparoscopic surgeries will be given propofol infusion for maintenance of anaesthesia with a duration of about 2 hours

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1.ASA class 1 patients undergoing laparoscopic surgeries, age group between 18-65 yrs. 2.ASA class 2 patients undergoing laparoscopic surgeries, age group between 18-65 yrs.

ExclusionCriteria

Details

1.Previous history of post-operative nausea and vomiting
2.History of motion sickness
3.Smoker
4. Pregnant or nursing mother
5.History of hypersensitivity to any of the study drugs.

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

An Open list of random numbers

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
To find the incidence of post-operative nausea and vomiting in patients receiving isoflurane inhalation and propofol infusion for maintenance of anaesthesia	Postoperatively,0-2 hr in recovery room,2-24 hr in post-operative ward

Secondary Outcome

Outcome	TimePoints
Haemodynamic parameters like MAP, HR, SPO2 & ETCO2 during the intra-operative period	Intraoperatively,vital parameters will be assessed every 15 mins

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
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

N/A

Date of First Enrollment (India)

17/07/2025

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

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 - NO

Brief Summary

This study is undertaken for comparative evaluation of isoflurane inhalation and propofol infusion for maintenance of anaesthesia on the incidence of post-operative nausea and vomiting in patients undergoing laparoscopic surgeries. incidence and severity of post-operative nausea and vomiting will be recorded along with the intraoperative haemodynamic parameters.