CTRI

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CTRI Number

CTRI/2025/07/091176 [Registered on: 18/07/2025] Trial Registered Prospectively

Last Modified On:

17/07/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Case Control Study

Study Design

Other

Public Title of Study

A study to observe the metabolic changes among overweight smokers vs overweight non-smokers coming for laparoscopic cholecystectomy

Scientific Title of Study

A prospective comparative study of metabolic parameter based on Arterial Blood Gas analysis in overweight smokers versus overweight nonsmokers undergoing laproscopic cholecystectomy

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Koppaka Naveen kumar
Designation	Postgraduate
Affiliation	Christian Medical college Vellore
Address	Department of Anaesthesia Christian Medical College Vellore Vellore TAMIL NADU 632004 India
Phone	9542014864
Fax
Email	naveenkk.dr@gmail.com

Details of Contact Person
Scientific Query

Name	Bernice Theodore
Designation	Associate professor
Affiliation	Christian Medical college
Address	Department of Anesthesia Christian Medical College Vellore Vellore TAMIL NADU 632004 India
Phone	9486843882
Fax
Email	berniceranjan@gmail.com

Details of Contact Person
Public Query

Name	Bernice Theodore
Designation	Associate professor
Affiliation	Christian Medical college
Address	Department of Anesthesia Christian Medical College Vellore Vellore TAMIL NADU 632004 India
Phone	9486843882
Fax
Email	berniceranjan@gmail.com

Source of Monetary or Material Support

Internal fluid research grant Christian Medical College Vellore 632004

Primary Sponsor

Name	Koppaka Naveen Kumar
Address	Department of Anesthesiology Christian Medical College Vellore 632004
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
Koppaka Naveen kumar	Christian Medical college Vellore	Department of surgery unit 4 and department of HepatoPancreatoBiliary surgery Vellore TAMIL NADU	9542014864 naveenkk.dr@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Ethics committe christian medical College Vellore	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: 4\|\|Measurement and Monitoring,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Inclusion criteria - Group I: patients with a history of smoking and a BMI greater than 25 planned for elective laproscopic cholecystectomy Group II: obese patients (BMI greater than 25) with no smoking history. Inclusion criteria were participants aged 20 to 60 years of both sexes who were planned for laproscopic cholecystectomy.

ExclusionCriteria

Details

Exclusion criteria were -
- patient refusal
- ASA 3 and 4
- gall bladder malignancy
- Asthma
- Cardiac disease

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To evaluate and compare the effect of carbon dioxide insufflation on arterial blood gas parameters like pH, pCO2 , and bicarbonate (HCO3) between overweight smokers vs overweight nonsmokers undergoing elective laparoscopic cholecystectomy	- pre operative (inside the theatre) - Intra operative - post operative ( in recovery room)

Secondary Outcome

Outcome	TimePoints
To observe if the blood gas changes are associated with the duration of smoking history	- pre operative (inside the theatre) - Intra operative - post operative ( in recovery room)

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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)

31/07/2025

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="2"
Days="15"

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

Smoking and CO2 pneumoperitoneum increases the risk of postoperative pulmonary complications in patients undergoing general anesthesia It has been demonstrated that pneumoperitoneum causes atelectasis in the dorsal regions of the lungs and causes the diaphragm to shift cranially due to which static elastance of the lung and chest wall and altered lung mechanics with increased airway pressure and decreased lung capacity The changes in lung mechanics that take place during surgery can heighten the risk of stress and strain on the lungs leading to ventilator-induced lung damage

These effects of atelectasis of basal lungs, increased airway pressures and decreased lung compliance are further aggravated in overweight individuals and among smokers This is reflected in the arterial blood gas as acidosis decreased HCO3 and increased CO2

Therefore, to determine whether these metabolic changes are significant or not, we are planning to assess the effect of overweight smokers vs overweight nonsmokers on metabolic parameters in patients coming for elective laparoscopic cholecystectomy surgery.