Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

Comparison of Postoperative Outcome and Cognitive Function After Sevoflurane and Propofol Anaesthesia for Cardiac Valvular Surgery With Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931877
• Other study ID #: Li Hong-Group
• Status: Completed
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: Xinqiao Hospital of Chongqing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

As the investigators know, postoperative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon, which affect patients' short-term and long-term outcome. Most patients will receive general anesthesia and cardiopulmonary bypass (CPB) during cardiac valvular surgery. Inhalation sevoflurane based and propofol based anesthesia are most commonly used strategy for general anesthesia. At present, it was unknown that which one is better in providing cerebral protection effect for patients undergoing cardiac valvular surgery with CPB. The current study aimed to explore the possible difference.

Description:

The investigators hypothesize that the incidence of postoperative cognitive dysfunction (POCD) is not different in patients received intravenous anesthetics propofol or sevoflurane for their cardiac valvular surgery. Two groups of general anesthetics (propofol or sevoflurane) are used to explore the possible difference of the postoperative outcome and the incidence of POCD. After cardiac valvular surgery with CPB, patients' POCD tests at 7 days after the surgery, and postoperative delirium, etc., are evaluated by different questionnaires. Also the blood sample of these patients are collected for detection of some stress hormones.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients who receive cardiac valvular surgery

• 18 to 65 years

• American society of anesthesiologists classification ?to ?

• education level higher than elementary school

Exclusion Criteria:

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

• Mini-mental State Examination (MMSE) score = 23.

• current use of sedatives or antidepressant

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

• accompanying liver or kidney function deficiency

• history of some endocrine disease

• alcoholism and drug dependence

• patients previously included in this study or currently included in the other clinical study

• patients who have second surgery during the study period

• difficult to follow up or patients with poor compliance

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Dysfunction

Intervention

Drug:
• sevoflurane

• propofol

Locations

Country	Name	City	State
China	Daping Hospital, Third Military Medical University	Chongqing	Chongqing
China	Xinan Hospital, Third Military Medical University	Chongqing	Chongqing
China	Xinqiao Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Degree of increase of stress hormones	Stress hormones include S-100ß, Il-6, etc.	Up to 24 hours after the surgery
Other	Length of ICU stay	The time for patient stay in ICU	Up to 7 days after the surgery
Other	Length of hospital stay	The time for patient stay in hospital	Up to 3 months after the surgery
Primary	Number of patients with postoperative cognitive dysfunction (POCD)	POCD is a composite outcome measure	From 7 days after the surgery to the day of discharge from hospital
Secondary	Postoperative delirium (POD)	POD is evaluated by a commonly used questionnaire	Up to 7 days after the surgery