NCT02489097

International Substudy Enigma2 on Postoperative Cognitive Disorders

Evaluating the Incidence and Association Between Nitrous Oxide and Postoperative Cognitive Disorders in Anaesthesia

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Numerous studies questioned the routine use of nitrous oxide (N2O), the oldest anaesthetic agent used since the development of anaesthesia care. Despite its wide use, there is sufficient doubt as to the risk-benefit profile. There is strong evidence that N2O is a major risk factor for postoperative nausea and vomiting. It is clear that (even) brief exposure to N2O impairs methionine synthetase, an enzyme required for DNA production, red and white blood cell formation. Tissue hypoxia may be more common. These adverse effects are enhanced in "sick" patients (ie. those at highest risk, with increased hospital length of stay and healthcare expenditure), and will be more likely in longer surgery. At the same time, observational studies and subgroup analysis of published trials suggest that N2O may have beneficial effects in preventing pain and postoperative cognitive disorders Outcome trial data on postoperative cognitive disorders are lacking in this area for an anaesthetic gas used in more than 90% of all surgery around the world. The enigma2 substudy as a nested study of the large Enigma2 randomised controlled trial aims at answering this question. The investigators aim at recruiting 420 patients in 2 of the 25 centres participating to the Enigma 2 trials, who are undergoing major surgery.

Conditions

• Anesthesia
• Delirium, Dementia, Amnestic, Cognitive Disorders

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-07-02
• Last updated: 2020-12-16

Locations

2 sites across 2 countries: China, Switzerland