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临床试验/CTRI/2024/09/073761
CTRI/2024/09/073761已完成不适用

To Study Variations in End Tidal Carbon Dioxide (EtCO2) Values in Patients Undergoing Endoscopic Procedures Under Total Intravenous Anaesthesia (TIVA): An Observational Study

Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年9月23日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
1
主要终点
To assess variations in End tidal carbon dioxide (EtCO2) values during endoscopic procedures

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

To assess variations in End tidal carbon dioxide (EtCO2) values during endoscopic procedures

时间窗: 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

次要结局

  • 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)

研究者

发起方
Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Prerana Nirav Shah

Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital

研究点 (1)

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