The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by First Affiliated Hospital, Sun Yat-Sen University
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: February 17, 2013
Last verified: February 2013
  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: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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 change in jugular vein bulb oxygen saturation between propofol and sevoflurane general anesthesia [ Time Frame: baseline ,every hour in the operation period,after extubation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the incidence of postoperative cognitive disfunction(POCD)between propofol and sevoflurane general anesthesia [ Time Frame: 7days after operation ] [ Designated as safety issue: No ]
  • 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


Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
sevoflurane
using sevoflurane during induction and maintenance of anesthesia
Procedure: sevoflurane
propofol
use propofol during induction and maintenance of anesthesia
Procedure: propofol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Contacts
Contact: Guo J Ying, Master 86-20-18665039959 gjunying@yahoo.com.cn
Contact: Huang W Qi, Master 86-20-13802963182

Locations
China, Guangdong
the First Affiliated Hospital of Sun YetSen University Recruiting
Guang Zhou, Guangdong, China, 510080
Contact: Guo J Ying, Master    86-2018665039959    gjunying@yahoo.com.cn   
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

No publications provided

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
Last Updated: February 17, 2013
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
Anoxia
Cognition Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Diseases
Nervous System Diseases
Propofol
Sevoflurane
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on July 23, 2014