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CTRI Number  CTRI/2025/03/083149 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 17/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Hemodynamic changes during laparoscopic surgeries under general anaesthesia 
Scientific Title of Study   A prospective observational study on hemodynamic changes during 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  Vashavee A 
Designation  Post graduate Msc Anaesthesia Technology 
Affiliation  SRM medical college and hospital SRM Nagar Potheri 
Address  Room no 22 Department of Anesthesiology SRM Medical college and hospital Room no 22 Department of Anesthesiology SRM Medical college and hospital Chennai TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  6385367423  
Fax    
Email  avashavee18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr C R Saravanan 
Designation  Professor  
Affiliation  SRM medical college and hospital SRM Nagar Potheri  
Address  Room no 22 department of anesthesiology SRM medical college and hospital room no 22 department of anesthesiology SRM medical college and hospital Chennai Tamil Nadu 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  9941308899  
Fax    
Email  drcrsaravanan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr C R Saravanan 
Designation  Professor  
Affiliation  SRM medical college and hospital SRM Nagar Potheri  
Address  Room no 22 department of anesthesiology SRM medical college and hospital room no 22 department of anesthesiology SRM medical college and hospital Chennai Tamil Nadu 603203 India


TAMIL NADU
603203
India 
Phone  9941308899  
Fax    
Email  drcrsaravanan@gmail.com  
 
Source of Monetary or Material Support  
SRM medical college hospital and research centre kattankulathur campus kancheepuram TAMIL NADU 603203 India 
 
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 C R Saravanan  SRM medical college and hospital  B206, B block, operation theatre complex department of anesthesia kattankulathur campus
Kancheepuram
TAMIL NADU 		 9941308899

drcrsaravanan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients admitted for elective laparoscopic procedure, SRM Medical College Hospital & Research centre
2.American Society of Anaesthesiologist (ASA) physical status I and II will be selected
 
 
ExclusionCriteria 
Details  1.Patient not willing to participate
2.Cardiovascular, Respiratory, and Cerebrovascular diseases
3.Patient with autonomic neuropathy
4.BMI more than 30 and less than 19
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To observe changes in Mean arterial pressure and heart rate after pneumoperitoneum during Laparoscopic surgeries.
 		 Before intubation, after intubation, after CO2 insufflation, after positioning, after 1 hour, after desufflation, after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor variations in airway pressures and capnography during the procedure.
 		 After intubation, after CO2 insufflation, after positioning, after 1 hour, after desufflation 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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)   31/03/2025 
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="3" 
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 prospective, observational study investigates the hemodynamic changes that occur during laparoscopic surgeries under general anesthesia, specifically focusing on variations in heart rate, mean arterial pressure, airway pressure, and lung compliance due to carbon dioxide insufflation and patient Positioning. Laparoscopic procedures, while beneficial in reducing postoperative pain and hospital stay, can cause significant physiological changes, necessitating careful anesthetic management. Since limited research exists on these effects, this study aims to provide a deeper understanding of how intraabdominal pressure and patient positioning influence hemodynamics, ultimately improving anesthesia protocols and patient safety. Conducted at SRM Medical College Hospital, this study includes 106 patients, with data recorded before and at various stages of surgery.  
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