TerminatedPhase 4

International Substudy Enigma2 on Postoperative Cognitive Disorders

Stopped: Interim analysis results showed futility

China, Switzerland140 participantsStarted 2013-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

Exclusion criteria

. Dementia (MMS test≤24)
. Parkinson Disease
. Patients taking regularly (\>2 weeks) tricyclic antidepressants or neuroleptics
. Patients suffering from Alcohol Dependency (WHO CRITERIA )
. Patients suffering from severe hypoacusis or visual loss or any other reason hindering the CANTAB battery testing process
. Patients with untreated deficit in Vitamin B6, B12 and folic acid
. Patients with marked impairment of gas-exchange requiring Fi02\> 0.5 intraoperatively
. Patients with specific circumstances where N2O is contraindicated (eg. volvulus, pulmonary hypertension, raised intracranial pressure) or the use of supplemental oxygen is planned (eg. colorectal surgery)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Memory, Executive function, Attention and psychomotor speed testing battery

Timeframe: Baseline before surgery

Memory, Executive function, Attention and psychomotor speed using CANTAB Cognitive testing battery at 7days following surgery

Timeframe: First assessment (7 days)

Memory, Executive function, Attention and psychomotor speed using CANTAB Cognitive testing battery at 3 months following surgery

Timeframe: Second assessment (3 months)

Trial details

NCT IDNCT02489097

SponsorUniversity Hospital, Geneva

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05

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