The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane

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

Study Overview

• Status: Completed
• Conditions: Postoperative Cognitive Dysfunction; Cerebral Hypoxia
• Intervention / Treatment: Procedure: propofol; Procedure: sevoflurane

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 Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guang Zhou, Guangdong, China, 510080
      • the First Affiliated Hospital of Sun Yetsen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing elective major surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Propofol-Abnormal; patients with preoperative SjvO2<55%,using the TIVA technology with propofol,	Procedure: propofol; use total intravenous anesthesia with propofol
Propofol-Normal; patients with preoperative SjvO2≥55%,using the TIVA technology with propofol,	Procedure: propofol; use total intravenous anesthesia with propofol
Sevoflurane-Abnormal; patients with preoperative SjvO2<55%,using the VIMA technology with sevoflurane,	Procedure: sevoflurane; use inhalation anesthesia with sevoflurane
Sevoflurane-Normal; patients with preoperative SjvO2≥55%,using the VIMA technology with sevoflurane,	Procedure: sevoflurane; use inhalation anesthesia with sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital Signs	heart rate, artery blood pressure,pulse oxygen saturation,temperature	baseline , evey hour in the operation,afte extubation
Blood Gas Analysis	including artery blood and blood from jugular vein bulb	baseline,every hour in the operation,after extubation

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Study Chair: Guo J Ying, Master, the First Affiliated Hospital of SunYetSen University

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: December 28, 2012
• First Posted (Estimate): December 31, 2012

Study Record Updates

• Last Update Posted (Estimate): September 18, 2015
• Last Update Submitted That Met QC Criteria: August 18, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: sevoflurane; propofol; postoperative cognitive dysfunction; jugular bulb oxygen saturation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Postoperative Complications; Neurocognitive Disorders; Signs and Symptoms, Respiratory; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications; Hypoxia; Hypoxia, Brain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: 伦审[2012]324号