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临床试验/CTRI/2026/03/106192
CTRI/2026/03/106192尚未招募不适用

Effects of a repeated verbal reminder of breathing pattern on emergence agitation after general anaesthesia for nose and sinus surgeries A one year randomised controlled trial

Rituparna Mishra1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年3月26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
70
试验地点
1

研究概览

简要总结

Emergence agitation is a well known early postoperative negative behavior having many complications .It occurs more frequently in nasal and sinus surgeries due to higher sense of suffocation due to nasal packing .This randomised controlled trial is designed to examine the impact of verbally reminding the patients of their breathing pattern on occurrence of emergence agitation following general anaesthesia in contrast to patients who simply heard their own names during extubation.

Patients will be assigned into two groups .In Interventional group the subject will be given information on course of general anaesthesia and instruction regarding breathing pattern will be provided during pre anaesthesia evaluation.

Then after subject enters the operating room before the induction of anaesthesia the subject will again be reminded and instruction of breathing pattern will be provided .

After the surgery at the start of emergence procedure they will be provided with repeated reminder of breathing pattern through headphones on patient ears with message playing on loop that Breathe through your mouth as your Nostril is packed you are now recovering from general anaesthesia after surgery open your eyes We are about to take out the tube Breathe calmly

No tactile stimulation will be allowed during the emergence .The Riker sedation agitation scale SAS will be used to score

The primary outcome will be the incidence of emergence agitation  which is defined as maximal SAS score more than equal to 5 .Secondary outcome will be Data on incidence of Dangerous emergence agitation SAS equal to 7 and Maximal SAS score during emergence and Vitals at 0 min 5 min and 10 min after extubation

Whereas those in the control group will not receive any instruction of breathing pattern previously and during extubation .They will verbally hear only their own name during extubation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
10.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA grade 1 and 2 Age between 10 to 60 years Elective Nose and Sinus Surgery requiring General Anaesthesia.

排除标准

  • ASA more than equal to 3 Pre existing conditions associated with neurological deficit Cognitive impairment or Hearing disorders Use of Antipsychotic Medications Patient refusal.

研究者

发起方
Rituparna Mishra
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Rituparna Mishra

Jawaharlal Nehru Medical College

研究点 (1)

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