The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane

Completed

• Conditions: Cerebral Hypoxia; Postoperative Cognitive Dysfunction
• Interventions: Procedure: propofol; Procedure: sevoflurane

• Registration Number: NCT01757561
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-28
• Study First Posted: 2012-12-31
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Results First Submitted: 2015-03-23
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-18
• Last Update Submitted: 2015-08-18
• Results First Posted: 2015-09-18
• Last Update Posted: 2015-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Propofol-Abnormal	propofol	patients with preoperative SjvO2\<55%,using the TIVA technology with propofol,
Sevoflurane-Abnormal	sevoflurane	patients with preoperative SjvO2\<55%,using the VIMA technology with sevoflurane,
Propofol-Normal	propofol	patients with preoperative SjvO2≥55%,using the TIVA technology with propofol,
Sevoflurane-Normal	sevoflurane	patients with preoperative SjvO2≥55%,using the VIMA technology with sevoflurane,

Primary Outcome Measures

Name	Time	Method
the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia	baseline ,every hour in the operation period,after extubation	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%.

Secondary Outcome Measures

Name	Time	Method
the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia	1-3days、5-7days after operation	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.
the Change in the Level of Serum BDNF(Brain-derived Neurotrophic Factor ) Between Propofol and Sevoflurane Anesthesia	before anesthesia, after extubation ,1day after operation
the Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia	before anesthesia,after extubation,1 day after operation

Trial Locations

Locations (1)

the First Affiliated Hospital of Sun YetSen University; 🇨🇳 Guang Zhou, Guangdong, China