CTRI Number |
CTRI/2025/04/084193 [Registered on: 04/04/2025] Trial Registered Prospectively |
Last Modified On: |
02/04/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
Comparison Of The Risk Of Complications Under General Anesthesia Among Smokers And Non-smokers |
Scientific Title of Study
|
A prospective observational study to compare the intraoperative complications among smokers and non-smokers, in patients undergoing 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 |
Farshana Jabin K |
Designation |
Post Graduate MSc Anaesthesia Technology |
Affiliation |
SRM medical college and hospital SRM Nagar Potheri |
Address |
Room no B22 Department of Anesthesiology SRM Medical college and hospital
Kancheepuram TAMIL NADU 603203 India |
Phone |
9846368543 |
Fax |
|
Email |
jabinrahman9020@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Dheepak Kumaran |
Designation |
Assistant professor |
Affiliation |
SRM medical college and hospital SRM Nagar Potheri |
Address |
Room no B22 Department of Anesthesiology SRM Medical college and hospital
Kancheepuram TAMIL NADU 603203 India |
Phone |
9073934944 |
Fax |
|
Email |
dheepaka@srmist.edu.in |
|
Details of Contact Person Public Query
|
Name |
Farshana Jabin K |
Designation |
Post graduate Msc Anaesthesia Technology |
Affiliation |
SRM medical college and hospital SRM Nagar Potheri |
Address |
Room no B22 Department of Anesthesiology SRM Medical college and hospital
Kancheepuram TAMIL NADU 603203 India |
Phone |
9846368543 |
Fax |
|
Email |
jabinrahman9020@gmail.com |
|
Source of Monetary or Material Support
|
SRM medical college hospital & research Centre SRM Nagar potheri 603203 |
|
Primary Sponsor
|
Name |
SRM Medical college and hospital |
Address |
SRM Medical College and Hospital SRM Nagar potheri 603203 |
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 |
Dr Dheepak Kumaran |
SRM Medical College and Hospital |
B206 B Block Anaesthesia
Department SRM Medical College Kattankulathur Campus Kancheepuram TAMIL NADU |
9846368543
jabinrahman9020@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee of SRM Medical College Hospital And Research centre |
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
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
ASA- I II III
Patients undergoing elective surgeries were recruited
Age between 18-70 will included |
|
ExclusionCriteria |
Details |
ASA- IV
Regional anaesthsia
Emergency surgeries
Pregnancy and infants
BMI above 30
Patient with pre-existing respiratory illness |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
to notice the incidence of intraoperative events such as in smokers and non-smokers
during general anesthesia. |
assessment will start after 10 minutes of intubation, till after 10 min of extubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
to compare and determine the risk factors involved in smokers and non-smokers during Intraoperative complication. |
assessment will start after 10 minutes of intubation, till after 10 min of extubation |
|
Target Sample Size
|
Total Sample Size="130" Sample Size from India="130"
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)
|
13/04/2025 |
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="0" Months="6" Days="1" |
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
|
Cigarette smoking is the most common form of tobacco use. The risks associated with cigarette smoking are a major concern for surgical patients undergoing general anesthesia. Tobacco smoking is a significant risk factor for cardiopulmonary complications both intraoperatively and postoperatively. Smokers may face higher risks due to lung and heart issues caused by smoking. By comparing smokers and non-smokers, we can identify specific complications that smokers are more likely to experience. The purpose of this study is to document the incidence of intraoperative complications during general anesthesia among self-reported smokers and compare them with those of non-smokers. A total of 130 patients, aged 18 to 70 years, undergoing elective surgeries will be enrolled, with 65 patients in each group. Patients classified as ASA-IV, undergoing emergency surgeries, pregnant individuals, infants, those with a BMI > 30, and those with pre-existing respiratory illnesses will be excluded. Intraoperative events such as oxygen desaturation, excessive secretions, laryngospasm, bronchospasm, and prolonged coughing during extubation will be recorded. This information will help medical professionals improve preoperative assessments and tailor anesthesia plans to reduce risks. Ultimately, this research aims to enhance patient outcomes, improve surgical safety, and develop targeted interventions for smokers, contributing to better overall healthcare quality. Understanding these differences is crucial for optimizing patient safety and care during surgeries. |