跳至主要内容
临床试验/CTRI/2024/12/077529
CTRI/2024/12/077529尚未招募不适用

Incidence of awareness during general anaesthesia in procedures using the apnoeic oxygenation technique : A prospective observational study.

Tata memorial centre1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2024年12月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
310
试验地点
1
主要终点
To determine the incidence of awareness during general anaesthesia in procedures in which apnoeic oxygenation is employed.

研究概览

简要总结

Accidental Awareness under General Anaesthesia (AAGA) is a serious but preventable complication that can lead to long term potential psychological consequences such as anxiety, depression, PTSD. Intraoperative awareness is characterized by intraoperative consciousness and postoperative recall of events. Patients may experience auditory recalls, recall of disastrous experience of hurtful surgical stimulation. In scenarios where neuromuscular blockade is used patients may experience a feeling of suffocation , paralysis which is new and deeply distressing for the patient . Patients undergoing procedures requiring apnoeic oxygenation techniques may be prone to AAGA . This is due to the use of neuromuscular blockade which blinds the practitioner to the most reliable indicator of insufficient anaesthesia as the patient cannot move in response to painful stimulus Also, in such procedures there is a rapid pace from induction to procedural stimulation. There are various methods to assess AAGA such as monitors like BP, heart rate, bispectral index, end tidal anaesthetic concentration , but none have been found to be totally efficacious in detecting awareness under anaesthesia. Incidence of AAGA was found out to be more when patients were specifically queried about it , in contrast to surveys which relied on retrospective reviews of patient initiated reports.

In this study we aim to find the incidence of awareness under anaesthesia when apnoeic oxygenation techniques were employed for procedures and to analyze the factors associated with the same.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients with age 18 years or more.
  • ASA grade 3 or less.
  • Patients with normal neurological status.
  • Procedures such as direct laryngoscopy, micro laryngoscopy, triple scopy, micro laryngoscopy with laser.

排除标准

  • Patients with age less than 18 years.
  • Refusal of consent by patient.
  • Procedures requiring upfront endotracheal intubation.
  • Procedures not requiring apnoeic oxygenation.
  • Patients who are not neurologically sound.
  • Patient requiring transfer to ICU after procedure.

结局指标

主要结局

To determine the incidence of awareness during general anaesthesia in procedures in which apnoeic oxygenation is employed.

时间窗: within 3 hours of intervention

次要结局

  • To assess factors associated with awareness during general anaesthesia(within 3 hours of intervention)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Nayana Amin

Tata memorial centre

研究点 (1)

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