Direct REporting of Awareness in MaternitY Patients

Obstetric Anesthesia Problems Clinical Trial

— DREAMY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03100396
• Other study ID #: 16.0063
• Secondary ID: 203113
• Status: Active, not recruiting
• Start date: May 22, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: January 2019
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3100
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Awareness, Anesthesia
• Intraoperative Awareness
• Obstetric Anesthesia Problems

Locations

Country	Name	City	State
United Kingdom	St. George's University Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of accidental awareness under general anaesthesia	Unintended awareness under general anaesthesia being reported following direct questioning with a Brice questionnaire	30 days
Secondary	Incidence and types of dreams under anaesthesia	Qualitative data on each awareness event; including recall, timing, understanding and emotional response	30 days
Secondary	Incidence of post-traumatic stress disorder (PCL-5 checklist)	Incidence of post-traumatic stress disorder symptoms following awareness events	12 months
Secondary	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
Secondary	Predictors of awareness based on patient, surgical and anaesthetic characteristics	Modifiable and non-modifiable characteristics associated with awareness	12 months
Secondary	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

External Links

•   Pan London Perioperative Audit and Research Network Site