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临床试验/CTRI/2025/01/079287
CTRI/2025/01/079287尚未招募不适用

Effect of intraoperative core temperature on recovery from general anaesthesia in adults

Dr Anjali T M Ollapally1 个研究点 分布在 1 个国家目标入组 317 人开始时间: 2025年2月3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
317
试验地点
1
主要终点
To correlate intraoperative and immediate postoperative core body temperature with time taken to recover from general anaesthesia.

研究概览

简要总结

Inadvertent intraoperative hypothermia (IPH), defined as a core body temperature <36℃, increases the risk of morbid cardiac events in the perioperative period (1),  increases surgical blood loss due to coagulopathy (2), alters anaesthetic drug kinetics which may lead to a delayed recovery (3), and results in  excessive shivering  in the post anaesthesia care unit. Shivering increases oxygen consumption and metabolic demand, in addition to being a cause of discomfort and distress to the patient (3)(4,5)

This study aims to document the incidence of IPH in an Indian tertiary hospital setting, and to evaluate the relation between intra- and post-operative core body temperature on recovery from anaesthesia. With this knowledge, we can institute appropriate preventive measures to aid a faster and smoother recovery from anaesthesia.

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

  • 1 Adults between 18 to 65 years 2 Posted for a surgery with a duration of 3 to 6 hours 3 American Society of Anaesthesiologists Physical Status I and II 4 Willing to consent.

排除标准

  • • Patients who are ASA PS III and IV posted for any surgery • Patients who will be electively ventilated postoperatively • Patients who are on Anti-epileptics, anti-psychotics etc, that affect anaesthetic drug metabolism • Patients who are undergoing Functional Endoscopic Sinus Surgery any other nasal surgery • Patients who have structural abnormalities of the nose or nasopharynx.

结局指标

主要结局

To correlate intraoperative and immediate postoperative core body temperature with time taken to recover from general anaesthesia.

时间窗: At completion of surgery. Only 1 time point

次要结局

  • To evaluate the difference in the intraoperative and immediate postoperative core body temperature between sexes, and to evaluate if these relate to recovery from general anaesthesia.(every 20 minutes intraoperatively)

研究者

发起方
Dr Anjali T M Ollapally
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anjali T M Ollapally

St Johns Medical College Hospital

研究点 (1)

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