Clinical trial

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

Name
ZZuo-POCD-1
Description
Post-operative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon. Most patients will receive general anesthesia during surgery. Two groups of general anesthetics are used for this purpose. We hypothesize that the incidence of POCD is not different in patients received intravenous anesthetics only or sevoflurane (a volatile anesthetic-based general anesthesia) for their major intra-abdominal surgery.
Trial arms
Trial start
2013-03-01
Estimated PCD
2019-04-01
Trial end
2019-04-01
Status
Completed
Phase
Early phase I
Treatment
Sevoflurane
Arms:
Sevoflurane & remifentanil
propofol
Arms:
propofol & remifentanil
remifentanil
Arms:
Sevoflurane & remifentanil, propofol & remifentanil
Size
684
Primary endpoint
Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)
At 7 days after the surgery
Eligibility criteria
Inclusion Criteria: 1. major elective gastrointestinal, gynecological, prostate or bladder surgery patients who are ≥ 60 years old. 2. the surgery is laparoscopic 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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 684, 'type': 'ESTIMATED'}}
Updated at
2023-06-22

1 organization

3 products

1 indication

Product
propofol