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The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jun-ying Guo, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01757561
First received: December 18, 2012
Last updated: August 18, 2015
Last verified: August 2015
  Purpose
the purpose of this study is to investigate whether propofol and sevoflurane have difference effect on cerebral oxygenation .

Condition Intervention
Cerebral Hypoxia
Postoperative Cognitive Dysfunction
Procedure: propofol
Procedure: sevoflurane

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia [ Time Frame: baseline ,every hour in the operation period,after extubation ] [ Designated as safety issue: No ]
    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:
  • the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia [ Time Frame: 1-3days、5-7days after operation ] [ Designated as safety issue: No ]
    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 [ Time Frame: before anesthesia, after extubation ,1day after operation ] [ Designated as safety issue: No ]
  • the Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia [ Time Frame: before anesthesia,after extubation,1 day after operation ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Vital Signs [ Time Frame: baseline , evey hour in the operation,afte extubation ] [ Designated as safety issue: No ]
    heart rate, artery blood pressure,pulse oxygen saturation,temperature

  • Blood Gas Analysis [ Time Frame: baseline,every hour in the operation,after extubation ] [ Designated as safety issue: No ]
    including artery blood and blood from jugular vein bulb


Biospecimen Retention:   Samples Without DNA
serum

Enrollment: 144
Study Start Date: December 2012
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients undergoing elective major surgery
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757561

Locations
China, Guangdong
the First Affiliated Hospital of Sun YetSen University
Guang Zhou, Guangdong, China, 510080
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Study Chair: Guo J Ying, Master the First Affiliated Hospital of SunYetSen University
  More Information

Responsible Party: Jun-ying Guo, Attending physician, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01757561     History of Changes
Other Study ID Numbers: 伦审[2012]324号 
Study First Received: December 18, 2012
Results First Received: March 23, 2015
Last Updated: August 18, 2015
Health Authority: China: Ethics Committee

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
jugular bulb oxygen saturation
postoperative cognitive dysfunction
propofol
sevoflurane

Additional relevant MeSH terms:
Hypoxia, Brain
Brain Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Central Nervous System Diseases
Nervous System Diseases
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on September 27, 2016