跳至主要内容
临床试验/CTRI/2024/05/067800
CTRI/2024/05/067800已完成2/3 期

A comparitive study of opioid free anesthesia with opioid base anesthesia for recovery characteristics and postoperative cognitive dysfunction after mastoidectomy surgeries

Preethi S1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
1)Emergence time

研究概览

简要总结

Opioid free anesthesia is a technique where no intraoperative opioid is administered during anesthetic management  and is usually achieved through sympatholysis, analgesia and anesthesia with DEXMEDETOMIDINE. Because of concern that opioids might cause perioperative respiratory depression, substitution with DEXMEDETOMIDINE will be helpful with analgesic and sympatholytic properties. It can allow for faster awakening and thus an earlier neurological examination by decreasing necessary volatile agent and opioid doses.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor 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

  • Age between 18 to 65 years ASA physical status 1 and 2.

排除标准

  • Taking opioid for chronic pain Pregnant and nursing women GCS less than 15 and heart rate less than 50 per min Allergic to study medications Psychiatric disorder and electrolyte imbalance Hepatic and renal insufficiency Unstable cardiorespiratory disorder.

结局指标

主要结局

1)Emergence time

时间窗: 1)Emergence time from administration of reversal agent to eye opening | 2)Extubation time from adminstration of reversal agent to tracheal extubation | 3)recovery of cognitive functions assessed using Short Orientation Memory Concentration test ater extubation at 5, 10 and 15mins

2)Extubation time

时间窗: 1)Emergence time from administration of reversal agent to eye opening | 2)Extubation time from adminstration of reversal agent to tracheal extubation | 3)recovery of cognitive functions assessed using Short Orientation Memory Concentration test ater extubation at 5, 10 and 15mins

3)recovery of cognitive functions

时间窗: 1)Emergence time from administration of reversal agent to eye opening | 2)Extubation time from adminstration of reversal agent to tracheal extubation | 3)recovery of cognitive functions assessed using Short Orientation Memory Concentration test ater extubation at 5, 10 and 15mins

次要结局

  • 1) Intraoperative hemodynamic stability(2)Postoperative pain assessment)

研究者

发起方
Preethi S
申办方类型
Other [Self financing]
责任方
Principal Investigator
主要研究者

Preethi S

Sri Ramachandra Institute Of Higher Education And Research

研究点 (1)

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