The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757561
• Other study ID #: ??[2012]324?
• Status: Completed
• Phase: N/A
• First received: December 18, 2012
• Last updated: August 18, 2015
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: August 2015
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

the purpose of this study is to investigate whether propofol and sevoflurane have difference effect on cerebral oxygenation .

Description:

the purpose of this study:(1) to investigate the incidence of preoperative cerebral oxygenation abnormity (SjvO2 <55%) and its relationship with intraoperative cerebral desaturation and POCD. (2) To investigate the change of intraoperative cerebral oxygen supply and demand balance and the incidence of cerebral desaturation in patients with abnormal preoperative cerebral oxygenation during sevoflurane anesthesia. (3)To investigate the incidence of early POCD in patients with abnormal preoperative cerebral oxygenation during sevoflurane and propofol anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• scheduled to take major surgery under general anesthesia over 18 years old classified as ASA class three or less

Exclusion Criteria:

• have a diagnosis of cerebrovascular disorder

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Hypoxia
• Cognition Disorders
• Hypoxia, Brain
• Postoperative Cognitive Dysfunction

Intervention

Procedure:
• propofol
use total intravenous anesthesia with propofol
• sevoflurane
use inhalation anesthesia with sevoflurane

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Sun YetSen University	Guang Zhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vital Signs	heart rate, artery blood pressure,pulse oxygen saturation,temperature	baseline , evey hour in the operation,afte extubation	No
Other	Blood Gas Analysis	including artery blood and blood from jugular vein bulb	baseline,every hour in the operation,after extubation	No
Primary	the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia	SjvO2 were measured before anesthesia, after intubation, every hour during operation, after extubation by jugular vein blood and atrial blood gas analysis.The incidence of intraoperative cerebral desaturation was recorded when SjvO2<50%.	baseline ,every hour in the operation period,after extubation	No
Secondary	the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia	The incidence of early POCD was recorded. The MMSE score and the Montreal cognitive assessment (MoCA) score were recorded 1day before surgery, 1-3 day after surgery and 5-7 day after surgery. The POCD was defined as MMSE score illiterate group = 17, primary and secondary school group = 20, junior high school and above group = 24,or the MoCA score decreased 20% with the baseline.	1-3days?5-7days after operation	No
Secondary	the Change in the Level of Serum BDNF(Brain-derived Neurotrophic Factor ) Between Propofol and Sevoflurane Anesthesia		before anesthesia, after extubation ,1day after operation	No
Secondary	the Change in the Level of Serum s-100ß Between Propofol and Sevoflurane Anesthesia		before anesthesia,after extubation,1 day after operation	No