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临床试验/CTRI/2024/01/061925
CTRI/2024/01/061925尚未招募Unknown

Comparative study of recovery characteristics between sevoflurane and desflurane in laparoscopic cholecystectomy patients under general anaesthesia in Regional Institute of Medical Sciences Hospital- a randomized clinical trial.

Regional Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月3日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
入组人数
60
试验地点
1
主要终点
The primary outcome of this study will be the time interval from the stoppage of inhalational anaesthetics to the time to spontaneous eye opening, time to obey commands, time to extubation and time to reach modified Aldrete score of 9.

研究概览

简要总结

Sevoflurane and desflurane are the newer inhalational volatile anaesthetics with properties close to ideal and have been an important agent used in the maintenance of anesthesia. Some previous studies have highlighted that desflurane provided rapid and stable emergence than sevoflurane in many surgical day care procedures. Desflurane however has been not used in induction due to its propensity to cause airway irritation, cough, larngospasm and profuse secretion in some studies.  Laparoscopic cholecystectomy surgery is usually a minimal invasive one which offers reduced morbidities, lesser operative time and early return to normal activities.

The present study will be conducted to compare the recovery characteristics of sevoflurane and desflurane in laparoscopic cholecystectomy under general anaesthesia and will compare the time interval from the stoppage of inhalational anaesthetics to the time to spontaneous eye opening, time to obey commands, time to extubation and time to reach  modified Aldrete score of 9. The study has been planned as there is paucity of literatures comparing these two agents on laparoscopic cholecystectomy which is the most common operative procedure in the Institute and it has also not been undertaken in this part of our ethinicity

A total of 60 patients, aged 18 to 55 years belonging to American society of Anaesthesiologists (ASA) I and II, undergoing laparoscopic cholecystectomy under general anaesthesia will be divided into two groups (Group A and Group B) by block randomization. Group A patients will receive Sevoflurane as maintenance agent with concentration decided by Bispectral Index Score (BIS) and hemodynamics parameters whlie Group B patients will receive Desflurane as maintenance agent with concentration decided by Bispectral Index Score (BIS) and hemodynamics parameters.The time interval from the stoppage of inhalational anaesthetics to the time to spontaneous eye opening, time to obey commands, time to extubation and time to reach  modified Aldrete score of 9 will be recorded in minutes.The hemodynamics parameters such as blood pressure and heart rate at 5 minutes, 10th minutesthereafter for every 10 minutes and at immediate postoperative period, side effects such as coughing, emergence agitation, nausea and vomiting, laryngospasm, excessive secretion, desaturation, etc will also be assessed.

The findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analysed and inference will be drawn. The study will be conducted after getting due approval from the Research Ethics Board of the Institute and after registration with the Clinical Trial Registry of India.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients of both sex with American Society of Anesthesiologist (ASA) physical grade I or II 2.Patients of age group 18 to 55 years of Manipuri ethnicity undergoing laparoscopic cholecystectomy under general anaesthesia.

排除标准

  • 1.History of use of hypnotics or antipsychotics in the last 30 days 2.History of cerebrovascular diseases, chronic kidney diseases, significant cardiovascular diseases, chronic obstructive pulmonary diseases, etc.
  • 3.Pregnant patient, patient refusal and history of allergy to any medication 4.Surgeries lasting more than one hour.
  • 5.Body mass index more than 30.

结局指标

主要结局

The primary outcome of this study will be the time interval from the stoppage of inhalational anaesthetics to the time to spontaneous eye opening, time to obey commands, time to extubation and time to reach modified Aldrete score of 9.

时间窗: The assesment will be done from the stoppage of inhalational anaesthetic to spontaneous recovery, i.e at 5 and 10 minutes after the stoppage.

次要结局

  • The secondary outcomes will includehemodynamics parameters such as blood pressure and heart rate at 5 minutes, 10th minutes, thereafter for every 10 minutes and also at immediate postoperative period, side effects such as coughing, emergence agitation, nausea and vomiting, laryngospasm, excessive secretion, desaturation, etc(The recording will be done at 5th, 10th, every 10 minutes intraoperatively and immediate postoperative)

研究者

申办方类型
Government medical college

研究点 (1)

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