Direct REporting of Awareness in MaternitY Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Direct Reporting of Awareness in Maternity Patients: a Prospective Evaluation of Accidental Awareness Under General Anaesthesia in Obstetric Surgery Patients

Conditions
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Awareness, Anesthesia, Obstetric Anesthesia Problems

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of accidental awareness under general anaesthesia | Unintended awareness under general anaesthesia being reported following direct questioning with a Brice questionnaire | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and types of dreams under anaesthesia | Qualitative data on each awareness event; including recall, timing, understanding and emotional response | 30 days | 
| Incidence of post-traumatic stress disorder (PCL-5 checklist) | Incidence of post-traumatic stress disorder symptoms following awareness events | 12 months | 
| Predictors of post-traumatic stress disorder based on patient characteristics and type of awareness event | Characteristics associated with post-traumatic stress disorder following anaesthesia with awareness and without awareness | 12 months | 
| Predictors of awareness based on patient, surgical and anaesthetic characteristics | Modifiable and non-modifiable characteristics associated with awareness | 12 months | 
| Comparison of direct questioning vs. semi-structured interview schedule approaches to assessing the incidence of awareness | Response from the Brice questionnaire will be assessed against responses gathered in during semi-structured interview schedules | 12 months |