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临床试验/CTRI/2026/01/101328
CTRI/2026/01/101328尚未招募不适用

Correlation Between Intraoperative End Tidal Carbon Dioxide Value And Post Operative Oxygen Requirement In Patients Under Going Spinal Anaesthesia With Opioid As An Additive Drug Observational Cross Sectional Study.

Dr P Meghana1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To Prevent Respiratory Depression in Patients Under Going Spinal Anaesthesia With Opioid As An Additive Drug.

研究概览

简要总结

This is an observational cross-sectional study designed to evaluate the relationship between intraoperative end-tidal carbon dioxide Value levels and postoperative oxygen requirements in patients undergoing spinal anaesthesia with an opioid additive.

Spinal anaesthesia is commonly used for lower limb and lower abdominal surgeries. Intrathecal opioids enhance analgesia but may cause respiratory depression, leading to postoperative hypoxia. Monitoring intraoperative end-tidal carbon dioxide Value  provides an early indicator of ventilatory compromise, while postoperative oxygen requirement serves as a clinical marker of respiratory adequacy.

The study will be conducted in a tertiary care teaching hospital between August 2025 and January 2027, including 60 adult patients (ASA I–II, aged 18–65 years) scheduled for elective lower limb or lower abdominal surgeries under spinal anaesthesia with opioid additive.

Primary Objective: To evaluate the correlation between intraoperative end-tidal carbon dioxide Value  levels and postoperative oxygen requirement.

Secondary Objectives: To assess the requirement and duration of postoperative oxygen therapy and to analyze the relationship between intraoperative sedation and postoperative respiratory outcomes.

Intraoperative end-tidal carbon dioxide Value  will be monitored continuously using a sidestream capnograph, and postoperative oxygen saturation will be assessed for 24 hours in the Post Anaesthesia Care Unit. Supplemental oxygen will be provided if  Saturation falls below 92%.

The findings are expected to provide insights into predicting postoperative oxygen needs, enabling early identification of patients at risk of opioid-induced respiratory compromise and guiding safer perioperative management.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • ASA Physical Status 1 and 2 Patients scheduled for elective lower limb or lower abdominal surgery under spinal anaesthesia with opioid as and additive drug.

排除标准

  • Patients With Pre Existing respiratory disease.
  • Patient Requiring General Anaesthesia Or Patient Getting Converted To General Anaesthesia.
  • Patient With Known Allergy To Local Anaesthetics Or Opioids, Patients With Baseline Oxygen Saturation Less Than 94 Percentage In Room Air.

结局指标

主要结局

To Prevent Respiratory Depression in Patients Under Going Spinal Anaesthesia With Opioid As An Additive Drug.

时间窗: First 24hrs after surgery.

次要结局

未报告次要终点

研究者

发起方
Dr P Meghana
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

PMeghana

Shri Sathya Sai Medical College And Research Institute

研究点 (1)

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