CTRI

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CTRI Number

CTRI/2023/08/056848 [Registered on: 23/08/2023] Trial Registered Prospectively

Last Modified On:

07/08/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Comparing two different types of ventilation for patients undergoing laparoscopic surgeries

Scientific Title of Study

Comparative study of the efficacy of Volume control ventilation vs Pressure control ventilation on patients undergoing laparoscopic surgeries under general anaesthesia.

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Poornima D
Designation	Junior Resident
Affiliation	Jawaharlal Nehru Medical College
Address	Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MAHARASHTRA 442001 India
Phone	9962059998
Fax
Email	drpoornima151996@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Amol Singam
Designation	Professor
Affiliation	Jawaharlal Nehru Medical College
Address	Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MAHARASHTRA 442001 India
Phone	9422538005
Fax
Email	dramolsingam@gmail.com

Details of Contact Person
Public Query

Name	Dr Amol Singam
Designation	Professor
Affiliation	Jawaharlal Nehru Medical College
Address	Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MAHARASHTRA 442001 India
Phone	9422538005
Fax
Email	dramolsingam@gmail.com

Source of Monetary or Material Support

nil

Primary Sponsor

Name	Jawaharlal Nehru Medical College
Address	Datta Meghe Institute of Higher Education and Research Sawangi Meghe
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
nil	na

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Poornima D	Jawaharlal Nehru Medical College	Department of Anaesthesiology Shalinitai Meghe Superspeciality Hospital AVBRH campus Wardha MAHARASHTRA	9962059998 drpoornima151996@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Datta Meghe Institute of Medical Sciences	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	Pressure control ventilation	1. Adjusting the inspiratory pressure according to tidal volume 2. Frequency: One time 3. Duration: Intubation to extubation
Intervention	Volume control ventilation	1. Tidal volume will be set according to body weight 2. Frequency: One time 3. Duration: Intubation to extubation

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patients of any gender, ages 18 to 70. Patients in ASA Classes I and II. All patients who are willing to provide written, fully informed permission. The surgery duration between 60 and 120 minutes.

ExclusionCriteria

Details

ASA Class III and higher
Patients rejection
Male or female below the ages of 18 and above 70.
Patients who shouldnt have laparoscopic procedures
People who experience allergic responses to anaesthetic agents

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To conclude if volume control ventilation or pressure control ventilation is effective in laparoscopic surgeries which has less hemodynamic responses	Pre induction Induction 5 minutes 10 minutes 15 minutes 20 minutes 25 minutes 30 minutes 35 minutes 40 minutes 45 minutes

Secondary Outcome

Outcome	TimePoints
comparison of hemodynamic parameters	Pre induction Induction 5 minutes 10 minutes 15 minutes 20 minutes 25 minutes 30 minutes 35 minutes 40 minutes 45 minutes

Target Sample Size

Total Sample Size="82"
Sample Size from India="82"
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)

25/09/2023

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="2"
Months="0"
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 - NO

Brief Summary

A variety of disorders are surgically treated with laparoscopy. Its benefits are frequently considered as being less intrusive, giving superior cosmetic outcomes, and needing a shorter hospital stay because they are based on surgical knowledge and cutting-edge technology.However, doing laparoscopic surgery under general anaesthesia and pneumoperitoneum may result in adverse pulmonary physiological alterations. This study will make it feasible to choose between volume control ventilation and pressure control ventilation for patients having sedated laparoscopic procedures.After assigning the mode of ventilation 41 in each group the responses under general anaesthesia will be assessed namely the ventilatory and hemodynamic responses.Then comparison will be made for efficacy of pressure control or volume control ventilation and which has better patient outcome.