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临床试验/CTRI/2024/03/063503
CTRI/2024/03/063503尚未招募4 期

Comparison of Sevoflurane and Isoflurane on post operative cognitive dysfunction following laparoscopic cholecystectomy.

Rajendra Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年3月14日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
90
试验地点
1
主要终点
To find out how Sevoflurane differs from Isoflurane on affecting postoperative cognitive dysfunction following a laparoscopic cholecystectomy surgery.

研究概览

简要总结

Laparoscopic cholecystectomy has been traditionally performed under general anesthesia.

Sevoflurane is a halogenated inhalational agent containing fluorine.It is an excellent choice for smooth and rapid inhalational induction in pediatric and adult patients.The minimum alveolar concentration of Sevoflurane is 2.0%.

Isoflurane is a non-flammable volatile anaesthetic with a pungent etheral odor.The minimum alveolar concentration of Isoflurane is 1.2%.

Postoperative cognitive dysfunction is defined as a new cognitive impairment arising after a surgical or anaesthetic procedure.Its diagnosis requires both pre and postoperative psychometric testing.

The Montreal Cognitive Assessment was designed as a rapid screening instrument for mild cognitive dysfunction.It assesses different cognitive domains attention and concentration , executive functions , memory, language visuoconstructional skills , conceptual thinking, calculations and orientation. The total possible score is 30 points. A score of 26 or above is considered normal.The Montreal Cognitive Assessment has a sensitivity of more than 90 percent for detecting even mild cognitive dysfunction.

In our study we aim to compare the effect of Sevoflurane and Isoflurane on post-operative cognitive dysfunction following laparoscopic cholecystectomy.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Those willing to give written.
  • informed consent. 2.ASA physical status I and II patients.

排除标准

  • Refusal of the patient.
  • Age less than 18 years and more than 60 years.
  • Patients above ASA III grade.
  • 4.Patients who do not speak hindi or english.
  • Patients who do not have an elementary school education.

结局指标

主要结局

To find out how Sevoflurane differs from Isoflurane on affecting postoperative cognitive dysfunction following a laparoscopic cholecystectomy surgery.

时间窗: until 24 hours post-extubation after the procedure.

次要结局

  • 1.To compare the incidence and severity of post operative shivering between sevoflurane and isoflurane.(2.To find out the incidence of post operative nausea and vomiting between sevoflurane and isoflurane.)

研究者

申办方类型
Government medical college

研究点 (1)

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