跳至主要内容
临床试验/CTRI/2025/10/096148
CTRI/2025/10/096148尚未招募不适用

Monitoring Depth Of Anesthesia colon Bi Spectral Index versus Observer’s Assessment of Anxiety And Sedation Scale during Titrated Etomidate Induction.

BHOPAL MEMORIAL HOSPITAL AND RESEARCH CENTRE ICMR1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2025年11月7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
106
试验地点
1
主要终点
Assess the corelation between BIS value and OAAS at 5 comma 4 comma 3 comma 2 comma 1 for titrated Etomidate induction

研究概览

简要总结

This trial is conducted in order to evaluate the co relation between BIS Index and Observer Assessment of Alertness and sedation scale while giving a titrated dose of etomidate

In the parent study this evaluation was done using propofol and it was observed that patient has  a score of one in OAAS scale wirh a BIS index of varying between 70 to 80 and thus intubation was performed after giving adjuvants like fentanyl and then relaxant

My study is to evaluate the same using etomidate while also assessing the amount of drug that will used depending upon the preoperative anxiety score of the patient

This study will be conducted in 106 patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA GRADE I or II BMI 18 to 30 kg per metre square.

排除标准

  • Severe Heart lung kidney function disease Compromised Adrenal Function. Expected difficult intubation Hypoalbuminemia less than 2.5 mg per dl rule out Aspiration risks • Neurological.
  • schizophrenia, epilepsy, hearing, intellectual disability. • Psychiatric Disorder patients on anti psychotic drug treatment. Long term Sedation psychoactive drug intake Allergy Sepsis or Septic shock.

结局指标

主要结局

Assess the corelation between BIS value and OAAS at 5 comma 4 comma 3 comma 2 comma 1 for titrated Etomidate induction

时间窗: ASSESSMENT OF THE OAAS WITH AMOUNT OF DRUG USED WITH VITALS IS DONE AT 1 MINUTE 2 3 4 5 MINUTES UNTIL A SCORE OF OAAS 1 IS ACHIEVED WHICH IS NO RESPOSNSE

Corelation between patients preOp Anxiety score and total amount of drug used to achieve OAAS of 1

时间窗: ASSESSMENT OF THE OAAS WITH AMOUNT OF DRUG USED WITH VITALS IS DONE AT 1 MINUTE 2 3 4 5 MINUTES UNTIL A SCORE OF OAAS 1 IS ACHIEVED WHICH IS NO RESPOSNSE

次要结局

未报告次要终点

研究者

发起方
BHOPAL MEMORIAL HOSPITAL AND RESEARCH CENTRE ICMR
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Anurag Yadava

Bhopal Memorial Hospital and Research Centre

研究点 (1)

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