International Substudy Enigma2 on Postoperative Cognitive Disorders

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02489097
• Date of registration: 26/06/2015
• Prospective Registration: No
• Primary sponsor: University Hospital, Geneva
• Public title: International Substudy Enigma2 on Postoperative Cognitive Disorders ISEP
• Scientific title: Evaluating the Incidence and Association Between Nitrous Oxide and Postoperative Cognitive Disorders in Anaesthesia
• Date of first enrolment: June 2013
• Target sample size: 420
• Recruitment status: Suspended
• URL: https://clinicaltrials.gov/show/NCT02489097
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

China, Switzerland

Contacts

• Name: Myles Paul, MD, FANZCA
• Affiliation: Bayside Health

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Anesthesia

Delirium, Dementia, Amnestic, Cognitive Disorders

Intervention(s)

Other: Placebo

Drug: Nitrous Oxide

Primary Outcome(s)

Memory, Executive function, Attention and psychomotor speed using CANTAB Cognitive testing battery [Time Frame: Baseline before surgery]

Memory, Executive function, Attention and psychomotor speed using CANTAB Cognitive testing battery at 7days following surgery [Time Frame: First assessment (7 days)]

Memory, Executive function, Attention and psychomotor speed using CANTAB Cognitive testing battery at 3 months following surgery [Time Frame: Second assessment (3 months)]

Secondary Outcome(s)

Quality of life [Time Frame: 3 months]

Hospital stay [Time Frame: up to a maximum of 3 months]

ICU stay [Time Frame: up to a maximum of 3 months]

Secondary ID(s)

NAC 08-021

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Prince of Wales Hospital, Shatin, Hong Kong

Chinese University of Hong Kong