Clinical trial NCT03100396: Direct REporting of Awareness in MaternitY Patients
Official title: Direct Reporting of Awareness in Maternity Patients: a Prospective Evaluation of Accidental Awareness Under General Anaesthesia in Obstetric Surgery Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Awareness, Anesthesia
Obstetric Anesthesia Problems
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 3100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing obstetric-indication surgery under general anaesthesia

Brief summary: 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: 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:

1. What is the last thing you remember before going to sleep?
2. What is the first thing you remember after waking up?
3. Do you remember anything between going to sleep and waking up?
4. Did you dream during your procedure?
5. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of accidental awareness under general anaesthesia
timeFrame: 30 days
Secondary outcomes:
measure: Incidence and types of dreams under anaesthesia
timeFrame: 30 days
measure: Incidence of post-traumatic stress disorder (PCL-5 checklist)
timeFrame: 12 months
measure: Predictors of post-traumatic stress disorder based on patient characteristics and type of awareness event
timeFrame: 12 months
measure: Predictors of awareness based on patient, surgical and anaesthetic characteristics
timeFrame: 12 months
measure: Comparison of direct questioning vs. semi-structured interview schedule approaches to assessing the incidence of awareness
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St. George's University Hospital
Study officials:
affiliation: St George's, University of London
name: Peter M Odor
role: STUDY_CHAIR
References:
citation: Odor PM, Bampoe S, Lucas DN, Moonesinghe SR, Andrade J, Pandit JJ; DREAMY Investigators Group. Protocol for direct reporting of awareness in maternity patients (DREAMY): a prospective, multicentre cohort study of accidental awareness during general anaesthesia. Int J Obstet Anesth. 2020 May;42:47-56. doi: 10.1016/j.ijoa.2020.02.004. Epub 2020 Feb 14.