A Randomized Controlled Trial of Recovery Profile when Switching From Isoflurane to Sevoflurane or Desflurane in Patients Undergoing Elective Non-Malignant Hepatobiliary Surgeries under General Anaesthesia
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Recovery profile after recovery from general anaesthesia based on CAM score (Confusion assessment score) where 0-2 means no delirium, 3-5 means mild to moderate delirium and 6-7 means severe delirium
研究概览
简要总结
Proposed Topic of Research: A RANDOMIZED CONTROLLED TRIAL OF RECOVERY PROFILE WHEN SWITCHING FROM ISOFLURANE TO SEVOFLURANE OR DESFLURANE IN PATIENTS UNDERGOING ELECTIVE NON-MALGNANT HEPATOBILIARY SURGERIES UNDER GENERAL ANAESTHESIA
Objective of Proposed Research:
To identify whether switching from Isoflurane to Desflurane or Sevoflurane towards the end of surgery can combine the advantages of Desflurane or Sevoflurane with the low cost of isoflurane
Background of Present Study:
The lower solubility of sevoflurane and desflurane allows for more rapid emergence from anaesthesia than with anaesthesia with the highly soluble but much cheaper isoflurane. Cost control is a necessary condition particularly in low resource setups that are highly prevalent in India. Hence in this study, we aim to determine whether changing from isoflurane to these more soluble compounds towards the end of surgery will provide the advantage of a cheaper overall cost along with the advantages of rapid emergence compared to using a single agent alone.
Methodology:
This is a single centre, prospective, randomized study on patients undergoing elective non-malignant hepatobiliary surgeries under general anaesthesia in the surgery OT of Midnapore Medical College & Hospital. A total of 90 patients will be equally divided into 3 groups where 1 group will receive only one inhalational agent, i.e., isoflurane (Group I). One group will be switched from isoflurane to sevoflurane (Group IS) and another from isoflurane to desflurane (Group ID). Anaesthetic and surgical management will be standardized in each group. Switching will be done when closure of abdominal muscle layer is started. The required parameters will be monitored in the intraoperative period and in the post operative period till complete recovery occurs.
Expected Outcome:
It is expected that one or both cross-over groups will have both good emergence and recovery as well as low cost when compared to the non-crossover group. However, our null hypothesis is that there will not be any statistically significant difference between all the groups. The outcome will be evident after proper statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients undergoing elective non-malignant hepatobiliary surgeries
- •ASA I, II patients.
排除标准
- •Severe ischemic heart disease, coagulopathy, chronic obstructive pulmonary disease, neuromuscular disorders Pregnant and lactating mothers Body mass index more than 30kg/m2 Allergy to drugs used in study or history of malignant hyperthermia in the family Any event other than switching inhalational drugs which cause their stoppage during study Surgery duration less than 90minutes or more than 3 hours.
结局指标
主要结局
Recovery profile after recovery from general anaesthesia based on CAM score (Confusion assessment score) where 0-2 means no delirium, 3-5 means mild to moderate delirium and 6-7 means severe delirium
时间窗: Outcome will be assessed at: After surgery at extubation, 1,2,4,6,8,10,15,20,25,30,45,60,75,90 and 120 minutes post extubation
次要结局
- Monitoring hemodynamic parameters and recovery parameters in the intraoperative and post-operative period like mean arterial pressure, heart rate, SpO2, respiratory rate, tidal volume, MAC, PEEP and ETCO2 in the intra operative period and Mean arterial pressure, heart rate, SPO2, Respiratory rate, VAS score and Ramsay sedation score, GCS and Post operative nausea and vomiting in the post operative period(1. Intraoperative time points are: 0,3,6,9,12,15,18,21,24, 27,30,35,40,45,50,55,60,65,70,75,80,85,90,95,100,105,110,115,120,125,130,135,140,145,150,155,160,165,170,175,180 minutes)
研究者
Dr Sagnik Datta
Midnapore Medical College & hospital