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International Substudy Enigma2 on Postoperative Cognitive Disorders

NCT02489097 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2020-12-16

No results posted yet for this study

Summary

The study is a substudy of the Enigma2 trial (NCT00430989) which aims at investigating the effectiveness and safety of nitrous oxide (N2O) in anaesthesia.The substudy focus is on postoperative cognitive disorders.

Substudy Hypothesis: In patients undergoing anaesthesia for major surgery, administration of N2O will reduce postoperative cognitive disorders when compared with otherwise identically managed surgical patients not receiving N2O as a component of their anaesthesia.

Conditions

  • Anesthesia
  • Delirium, Dementia, Amnestic, Cognitive Disorders

Interventions

DRUG

Nitrous Oxide

Administration of a concentration of 70% Nitrous Oxide with 30% Oxygen in the anaesthetic gas mixture

OTHER

Placebo

Administration of a concentration of 70% Air with 30% Oxygen in the anaesthetic gas mixture

Sponsors & Collaborators

  • Prince of Wales Hospital, Shatin, Hong Kong

    collaborator OTHER

  • Chinese University of Hong Kong

    collaborator OTHER

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Myles Paul, MD, FANZCA · Bayside Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • China
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02489097 on ClinicalTrials.gov