Direct Reporting of Awareness in Maternity Patients: a Prospective Evaluation of Accidental Awareness Under General Anaesthesia in Obstetric Surgery Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 3,100
- 试验地点
- 1
- 主要终点
- Incidence of accidental awareness under general anaesthesia
研究概览
简要总结
DREAMY is a prospective, multi-centre observational cohort study using a mixed methods approach to provide quantitative and qualitative data on accidental awareness under general anaesthesia (AAGA) in obstetric surgery patients. Obstetric patients undergoing surgery, such as emergency caesarian section under general anaesthesia, are thought to be at higher risk than any other surgical cohorts for AAGA. Patients recruited to the study will be screened for AAGA using a standardised questionnaire on three occasions over 30 days. Follow up with structured interviews for all AAGA patients will occur over 12 months.
详细描述
Background: The challenges of obstetric general anaesthesia practice - including the use of rapid sequence induction, neuromuscular blockade and short duration between anaesthetic induction and start of surgery - may contribute to a higher risk of awareness under general anaesthesia (AAGA) in these patients. The 2014 Royal College of Anaesthetists/Association of Anaesthetists of Great Britain and Ireland National Audit Project 5 highlighted a higher risk of spontaneously reported AAGA in obstetric patients, but it remains unclear what the full (i.e. non-spontaneously reported) risk is. The aim of DREAMY is to establish the incidence of AAGA following general anaesthesia in obstetric surgery patients.
Methods: A standardised Brice questionnaire will be used to screen for recall of intraoperative events in women meeting the eligibility requirements. Questions asked are:
- What is the last thing you remember before going to sleep?
- What is the first thing you remember after waking up?
- Do you remember anything between going to sleep and waking up?
- Did you dream during your procedure?
- What was the worst thing about your operation?
The validity of the AAGA incidence will be improved by repetition of the questionnaire on three occasions over thirty days and triangulating using structured follow up interviews in all participants reporting AAGA in questionnaire responses. Participants will be followed up over 12 months and asked for self-reported symptoms of post-traumatic stress disorder (PTSD) using the PCL-5 checklist. The research is being run as a multi-centre, descriptive study over 12 months. General condition and details of the anaesthetic procedure will also be recorded for a logistic regression analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female adults (≥18 years) of ≥ 24/40 gestation
- •Receiving general anaesthesia (de novo or regional anaesthesia converted to GA) for surgery with an obstetric indication (e.g. emergency caesarean section, manual removal of placenta, examination under anaesthesia)
排除标准
- •Patients too unwell or confused to be able to complete the questionnaire
- •Patient refusal
- •General anaesthesia for non-obstetric indication (e.g. colorectal or orthopaedic surgery in a pregnant patient)
- •Surgery ≥48 hours post-partum
- •Unable to communicate verbally/in writing in English language
结局指标
主要结局
Incidence of accidental awareness under general anaesthesia
时间窗: 30 days
Unintended awareness under general anaesthesia being reported following direct questioning with a Brice questionnaire
次要结局
- Predictors of post-traumatic stress disorder based on patient characteristics and type of awareness event(12 months)
- Predictors of awareness based on patient, surgical and anaesthetic characteristics(12 months)
- Comparison of direct questioning vs. semi-structured interview schedule approaches to assessing the incidence of awareness(12 months)
- Incidence and types of dreams under anaesthesia(30 days)
- Incidence of post-traumatic stress disorder (PCL-5 checklist)(12 months)