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临床试验/CTRI/2024/10/075436
CTRI/2024/10/075436尚未招募不适用

Randomised Comparative Study On Sevoflurane Consumption And Time To Tracheal Extubation By Using Bispectral Index Monitoring Versus End-Tidal Agent Concentration Monitoring In Patients Undergoing Sevoflurane Based General Anaesthesia, At S.M.S Medical College Jaipur

Department of AnaesthesiologySawai Man Singh Medical College And Attached Hospitals Jaipur1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年10月21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
64
试验地点
1
主要终点
1.To determine and compare the time to tracheal extubation under Sevoflurane based anaesthesia between BIS and ETAC monitoring.

研究概览

简要总结

Maintaining an optimal depth of anaesthesia during surgery is essential toprevent awareness and to ensure a rapid , smooth recovery. Clinical parameters like Heart rate , BP , increased secretions or movement are subjective and thus not reliable for assessing the depth if anaesthesia .Bispectral index(BIS) is developed from a processedelectroencephalogram and used in anaesthetised patients, has been shown to decrease theincidence of post-operative recall for intra operative awareness when maintained below

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Patients undergoing elective urology surgery under Sevoflurane based general anaesthesia between 60-120 minutes.
  • ASA grade I & II.Patients with BMI less than 30 kg per meter squared.

排除标准

  • 1.Patients with history of long term use of psychoactive and anticonvulsant medications.
  • 2.Patients with psychiatric illness, known or suspected electroencephalographic abnormalities (EEG).
  • 3.Patients with pre existing renal or hepatic diseases.
  • 4.Patients with preexisting pulmonary diseases.
  • 5.Patients with pre existing cardiac diseases.
  • Patients with anticipated difficult airway 7.Patients with dementia and stroke with residual neurological deficits.

结局指标

主要结局

1.To determine and compare the time to tracheal extubation under Sevoflurane based anaesthesia between BIS and ETAC monitoring.

时间窗: From baseline to completion of surgery every 5 minutes

2.To determine and compare the sevoflurane consumption in patients undergoing sevoflurane based general anesthesia between BIS and ETAC monitoring .

时间窗: From baseline to completion of surgery every 5 minutes

次要结局

  • 1.To determine and compare recovery time under Sevoflurane based anaesthesia between BIS and ETAC monitoring .

研究者

发起方
Department of AnaesthesiologySawai Man Singh Medical College And Attached Hospitals Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Siddhartha Sharma

Sawai Man Singh Medical College And Attached Hospitals

研究点 (1)

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