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Comparison of Total Intravenous Anesthesia With Sevoflurane-based Balanced Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients for Major Elective Intra-abdominal Surgery


Phase 4
60 Years
N/A
Open (Enrolling)
Both
Intra-abdominal Surgery

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Trial Information

Comparison of Total Intravenous Anesthesia With Sevoflurane-based Balanced Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients for Major Elective Intra-abdominal Surgery


Inclusion Criteria:



1. major elective gastrointestinal or gynecological surgery patients who are ≥ 60 years
old.

2. the surgery is open abdominal surgery and is expected to last for ≥ 2 hours under
general anesthesia and the patient will stay in hospital for at least 7 days after
surgery.

3. lack of serious hearing and vision impairment and be able to read so that
neurobehavioral tests can be performed.

Exclusion Criteria:

1. Patients are not expected to be alive for longer than 3 months.

2. Mini-mental State Examination (MMSE) [18] score ≤ 23.

3. history of dementia, psychiatric illness or any diseases of central nervous system.

4. current use of sedatives or antidepressant.

5. alcoholism and drug dependence.

6. patients previously included in this study (for patients who have second
intra-abdominal surgery during the study period).

7. difficult to follow up or patients with poor compliance.

8. uncontrolled hypertension (> 180/100 mmHg)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)

Outcome Time Frame:

At 7 days after the surgery

Safety Issue:

Yes

Authority:

China: Ethics Committee

Study ID:

ZZuo-POCD-1

NCT ID:

NCT01809041

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Intra-abdominal Surgery
  • Cognition Disorders

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