UnknownNot Applicable

Direct REporting of Awareness in MaternitY Patients

United Kingdom3,100 participantsStarted 2017-05-22

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence of accidental awareness under general anaesthesia

Timeframe: 30 days

Trial details

NCT IDNCT03100396

SponsorSt George's, University of London

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-08-31

View on ClinicalTrials.gov More Awareness, Anesthesia trials