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临床试验/CTRI/2020/03/024340
CTRI/2020/03/024340已完成不适用

Comparison between effect of bispectral index and minimum alveolar anaesthetic concentration monitoring on recovery profile in patients undergoing general anesthesia

Dr Aparna Abhijit Bagle Girwalkar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月4日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
to compare the effect of BIS or MAC monitoring on recovery profile of patients unergoing general anaesthesia

研究概览

简要总结

This study was conducted to investigate the effect of bispectral index (BIS) monitoring compared to the minimum alveolar anesthetic concentration (MAC) monitoring on recovery of patients undergoing isofluranebased general anesthesia. Materials and Methods: A total of 62 patients were randomly allocated to group B (BIS-guided) and group M (MAC-guided). Along with clinical hemodynamic monitoring for titration of isoflurane in group B, BIS was monitored and maintained between 40 and 60, whereas in group M, MAC was maintained between 0.7 and 1.3. The recovery profile was studied in terms of time to eye-opening, time to extubation, and time to achieve the modified Aldrete score ≥9 in both groups. Patients were followed up for any postoperative side effects and awareness during general anesthesia. Results: Group B and group M were comparable with respect to age, gender, duration of surgery, duration of anesthesia, and type of surgery. Median time to eye-opening was 4min in group B and 5min in group M (P < 0.001). The time to extubation was 8min in group B, compared to 11min in group M (P < 0.001). Furthermore, the time needed to achieve the modified Aldrete’s score of ≥9 was also shorter in group B (P < 0.001). No patients reported awareness during anesthesia.

Conclusion: The use of BIS monitoring hastens the extubation and recovery in patients undergoing general anesthesia

研究设计

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

入排标准

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

入选标准

  • patients with physical status asa 1 and 2 posted for surgeries under general anaesthesia.

排除标准

  • patietns with pyschiatric illness, clinically significant cardiovascular, respiratory, hepatic,neurological,long term drug therapy or alcohol abuse.

结局指标

主要结局

to compare the effect of BIS or MAC monitoring on recovery profile of patients unergoing general anaesthesia

时间窗: 1.5 years

次要结局

  • any perioperative complications or recall of intra operative events(1.5 years)

研究者

发起方
Dr Aparna Abhijit Bagle Girwalkar
申办方类型
Other [self]

研究点 (1)

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