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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  
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 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  
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 
 
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.
 
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