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CTRI Number  CTRI/2024/09/073761 [Registered on: 11/09/2024] Trial Registered Prospectively
Last Modified On: 23/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   To Study Changes in Levels of Carbondioxide in Expired Gas in Patients Undergoing Procedures that are done with the help of Endoscope which is a thin tube like instrument with a light and lens for viewing under anaesthesia medicines that are given by injections in veins 
Scientific Title of Study   To Study Variations in End Tidal Carbon Dioxide (EtCO2) Values in Patients Undergoing Endoscopic Procedures Under Total Intravenous Anaesthesia (TIVA): An Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prerana Nirav Shah 
Designation  Professor 
Affiliation  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital  
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9869117027  
Fax    
Email  pps@kem.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pravin Pandarinath Bodewar 
Designation  Resident 
Affiliation  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital 
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  09096574673  
Fax    
Email  PRAVINBODEWAR@GMAIL.COM  
 
Details of Contact Person
Public Query
 
Name  Dr Pravin Pandarinath Boderwar 
Designation  Resident 
Affiliation  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital 
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India


MAHARASHTRA
400012
India 
Phone  09096574673  
Fax    
Email  PRAVINBODEWAR@GMAIL.COM  
 
Source of Monetary or Material Support  
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India  
 
Primary Sponsor  
Name  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital  
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India  
Type of Sponsor  Government 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 Pravin Pandarinath Bodewar  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital   Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India
Mumbai
MAHARASHTRA 
9096574673

PRAVINBODEWAR@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe (IEC)-II)  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  End tidal carbon dioxide (EtCO2) values monitoring  End tidal carbon dioxide levels shall be monitored baseline, at the time of induction, during procedure every 10 minutes upto first 30 minutes, then every 15 minutes upto 1 hour, then every 30 minutes upto 2 hours, at the end of procedure and in recovery every 10 minutes for 30 minutes post procedure  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients age between 18– 65 years
Both gender
ASA physical status I II and III
Patient undergoing endoscopic procedures (eg ERCP colonoscopy) under TIVA
 
 
ExclusionCriteria 
Details  Patients who refuse to give consent to participate in study
Patients with history of respiratory disorders with pre op EtCO2 more than 40 or SpO2 less than 90%
Patients with trauma and bleeding on face where it is difficult to insert prongs and monitor EtCO2
Patients with Systolic blood pressure less than 90 mmHg heart rate less than 50 beats per min prior to procedure
Pre operatively presence of underlying disease requiring oxygen
Pregnant women
Patients who are intubated prior to procedure 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess variations in End tidal carbon dioxide (EtCO2) values during endoscopic procedures  baseline, at the time of induction, during procedure every 10 minutes upto first 30 minutes, then every 15 minutes upto 1 hour, then every 30 minutes upto 2 hours, at the end of procedure and in recovery every 10 minutes for 30 minutes post procedure 
 
Secondary Outcome  
Outcome  TimePoints 
To determine incidence of respiratory depression, severe hypoxia,patient and endoscopist satisfaction and interventions needed  baseline, at the time of induction, during procedure every 10 minutes upto first 30 minutes, then every 15 minutes upto 1 hour, then every 30 minutes upto 2 hours, at the end of procedure and in recovery every 10 minutes for 30 minutes post procedure 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/09/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  

Endoscopic procedures like ERCP and colonoscopy are common diagnostic and therapeutic interventions used to visualize and treat conditions within the gastrointestinal tract. These procedures involve the insertion of a flexible tube equipped with a camera through the mouth (ERCP) or rectum (colonoscopy), allowing physicians to examine and address various gastrointestinal issues. However patient needs to be under adequate depth of anaesthesia to allow smooth passage of endoscope.

Total intravenous anaesthesia(TIVA) with Fentanyl,propofol and Dexmeditidone,  often  used for endoscopic procedures, offers several advantages, such as precise control of drug administration, rapid onset and offset of anaesthesia, and a reduced risk of postoperative complications. Monitoring of patients during such procedures is of utmost importance to ensure their safety and well-being.

During endoscopic procedures, the medications used  can have significant effects on the patient’s respiratory function. Capnography is a non-invasive method of measuring end-tidal carbon dioxide (EtCO2) and  for real-time respiratory monitoring. Changes in EtCO2 levels can signal alterations in respiratory rate, tidal volume, and overall respiratory function.

In the present study we aim to study variations in End tidal carbon dioxide(EtCO2) values in endoscopic procedure like ERCP and colonoscopy which are done under total intravenous anaesthesia(TIVA). All patients who are undergoing endoscopic procedures like ERCP and colonoscopy will be considered for this study. Standard monitors like Electrocardiography, Blood pressure(BP) monitor will be attached to patient. A nasal canula with an sampling port will be connected to bedside monitor that displays a time based capnogram and  EtCO2values (in mm Hg), respiratory rate.

Incidence of respiratory depression, severe hypoxia, endoscopist satisfaction and interventions needed during endoscopic procedures done under total intravenous anaesthesia (TIVA) shall be looked for.

 
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