| 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
|
|
|
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
|
|
|
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. |