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临床试验/CTRI/2024/10/075652
CTRI/2024/10/075652尚未招募不适用

Effect of nasal clamping and mouth breathing training in reducing emergence delirium post endoscopic sinus surgery - randomised controlled study

Bangalore Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月29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
100
试验地点
1
主要终点
To assess emergence delirium post nasal surgery

研究概览

简要总结

Emergence delirium is a short term state of dissociation of consciousness during the recovery from general anaesthesia along with motor agitation,incoherence ,inconsolability and unresponsiveness.(1-3) It is the most common neuropsychiatric complications after surgery . Emergence delirium is self-limiting but sometimes the agitated behaviour may result in post anaesthesia care unit accidents.(4) Emergence delirium may be associated with increased risks of long term adverse outcomes like cognitive dysfunction and negative behaviour that cause lower quality of life, readmission to hospitals ,and even deaths.(5,6) Emergence delirium may arise by an imbalance between the patient’s arousal state and the recovery of consciousness. Interventional strategies like medical interventions - Gabapentin, Dexmeditomidine , Melatonin and Remelteon and non pharmacological interventions such as time and place orientation are employed to reduce the incidence of emergence delirium.(7,8)

During the emergence from anaesthesia, obstruction by nasal packing cause breathing difficulties and a feeling of suffocation due to forceful mouth breathing which increases the risk of emergence delirium. Risk factors for emergence delirium are age,smoking , pre-operative anxiety, types of operation, postoperative pain,etc .(9,10)

The study aims at evaluating the efficacy of preoperative patient training and training with nasal clamping and mouth breathing training on prevention of emergence delirium and to identify associated risk factors for emergence delirium.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to give written informed consent belonging to American Society of Anaesthesiologist I and II undergoing endoscopic sinus surgery, septoplasty and turbinoplasty requiring post surgery nasal packing.

排除标准

  • Patients not willing to give informed consent Patients with known allergy to any study drug.

结局指标

主要结局

To assess emergence delirium post nasal surgery

时间窗: To assess emergence delirium with RAS at 1min 5min 10 min 15 min 20 min 25 min 30 min 1hr

次要结局

  • To assess opiod requirements over 24 hrs post surgery(To assess NRS and rescue analgesia at immediately,30 min 1hr 2 hr 8hrs 12 hrs 24 hrs)
  • To assess haemodynamic parameters heart rate mean arterial pressure post operatively(To assess haemodynamic parameters heart rate mean arterial pressure immediately 30 min 1hr 2 hr 8hrs 12 hrs 24 hrs)

研究者

发起方
Bangalore Medical College and Research Institute
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sargam Gupta

Bangalore Medical College and Research Institute Bangalore

研究点 (1)

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