Status:
COMPLETED
Interaction of Cobalamin Status With Nitrous Oxide in Relation to Postoperative Cognitive Changes in the Elderly
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Avitaminosis
Delirium, Dementia, Amnestic, Cognitive Disorders
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
Low cobalamin (vitamin B12) levels are frequent in the elderly. Most often they reflect a mild metabolic abnormality without clinical symptoms (subclinical cobalamin deficiency). It is unclear if thes...
Detailed Description
Study Design: * Double-blind, randomized study of elderly patients scheduled for elective surgery under general anesthesia. * Medical, cobalamin-related, and demographic information; * Blood tests of...
Eligibility Criteria
Inclusion
- age \>60 years; elective surgery requiring general anesthesia for an hour or more; English speaker
Exclusion
- Surgery involving CNS, blood supply to head, or cardiovascular system; preexisting dementia, psychosis or stroke; contraindication to any of the planned anesthetic agents; exposure to nitrous oxide in past 6 months; clinical status other than ASA class 1 or 2; bronchospastic or chronic obstructive lung disease; use of cobalamin injections in past 6 months; serum creatinine \>1.8 mg.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
444 Patients enrolled
Trial Details
Trial ID
NCT00212147
Start Date
September 1 2003
End Date
August 1 2008
Last Update
August 8 2022
Active Locations (2)
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1
New York Methodist Hospital
Brooklyn, New York, United States, 11215
2
WeillMedical College of Cornell University
New York, New York, United States, 10021