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临床试验/CTRI/2025/11/097500
CTRI/2025/11/097500尚未招募不适用

A comparative study To evaluate the effect of remifentanil based TIVA versus balanced anaesthesia on emergence agitation in patients undergoing nasal surgeries.

MS Ramaiah Medical College1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年11月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
To determine the incidence of emergence agitation in remifentanil based TIVA group and Balanced Anaesthesia group based on RASS score.

研究概览

简要总结

Emergence agitation is an acute, self-limited and non-fluctuating state of psychomotor excitement. This hyperactive state is confined to the emergence period after general anaesthesia  Although the incidence rate of EA in adults range from 0.25% to 21.3% and time of onset typically lasts for about 15 min serious consequences can occur if patients with EA are not treated promptly. Emergence agitation can lead to serious consequences such as self-extubation, removal of catheters, haemorrhage, and even severe injuries from falling out of the bed. Furthermore, it may increase the demand on human resources and cause medical staff injuries . While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of emergence agitation in both adults and children. Various drugs and techniques have been proven effective in reducing the incidence of emergence agitation. Despite decades of research, studies on the occurrence rate, risk factors and prevention of emergence agitation in adult patients are still ongoing. In particular, opinions differ on the different effects of inhalation and intravenous anaesthesia. In prospective study of 1359 adult patients multivariate analysis showed that the method of anaesthesia did not affect occurrence of emergence agitation . Another prospective observational study of about 2000 adults reported that the use of volatile anaesthetic agents was associated with a higher occurrence rate of emergence agitation . Therefore the current study is designed to compare two standard techniques of anaesthesia that is remifentanil based TIVA versus balanced anaesthesia on emergence agitation.

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

  • Adult patient Aged 18-65 years.
  • Patients scheduled for elective nasal surgeries requiring GA.
  • ASA physical status 1.

排除标准

  • Patients with known allergies to remifentanil or propofol.
  • History of severe cardiovascular, hepatic, or renal diseases.
  • History of substance abuse, including alcohol,or narcotics.
  • Pregnancy or breastfeeding.
  • Patients with a history of significant psychiatric conditions including severe agitation, anxiety disorders or any other conditions leading to increased risk of agitation.
  • Emergency surgery cases.

结局指标

主要结局

To determine the incidence of emergence agitation in remifentanil based TIVA group and Balanced Anaesthesia group based on RASS score.

时间窗: Emergence agitation will be measured 2 minutes after extubation.

次要结局

  • Post-operative complications like post-operative nausea & vomiting, disorientation & shivering.(Immediately after arrival to post anaesthesia care unit,30 min after arrival,60min after arrival.)
  • Recovery time T0-T1.(Time from discontinuation of all anaesthetic agents to time taken by patient to open eyes to verbal commands.)
  • Time to extubation T1-T2.(Time from patient able to open eyes to verbal commands to extubation.)
  • Post-operative pain using NRS.(Immediately after arrival to post anaesthesia care unit ,30 min after arrival,60min after arrival .)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Soundarya D U

MS Ramaiah Medical College.

研究点 (1)

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