International Substudy Enigma2 on Postoperative Cognitive Disorders

• Status: Terminated
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Geneva
• Collaborators: Chinese University of Hong Kong; Prince of Wales Hospital, Shatin, Hong Kong
• Treatments: Nitrous Oxide

Criteria

Inclusion Criteria:

Adult males and females aged ≥ 45 years, undergoing noncardiac surgery and general anaesthesia that exceeds two hours.

At increased risk of cardiac events, defined as any of:

• history of coronary artery disease (angina, MI, Coronary revascularisation-Coronary Artery Bypass Graft (CABG) and Percutaneous Transluminal Coronary Angiography ( PTCA)-, positive stress testing, angiography/other imaging, Q waves on ECG)

• heart failure

• cerebrovascular disease due to atherothrombotic disease

• aortic or peripheral vascular disease

OR

three or more of the following risk factors: age ≥70 years, history of heart failure, diabetes (medicated), hypertension (medicated), preoperative serum creatinine >175 mmol/L, cholesterol ≥6.2 mmol/L, history of a transient ischemic attack (TIA),

Exclusion Criteria:

1. Dementia (MMS test≤24)

2. Parkinson Disease

3. Patients taking regularly (>2 weeks) tricyclic antidepressants or neuroleptics

4. Patients suffering from Alcohol Dependency (WHO CRITERIA )

5. Patients suffering from severe hypoacusis or visual loss or any other reason hindering the CANTAB battery testing process

6. Patients with untreated deficit in Vitamin B6, B12 and folic acid

7. Patients with marked impairment of gas-exchange requiring Fi02> 0.5 intraoperatively

8. 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)

9. N2O unavailable