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Completed

NCT Number: NCT01757561

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 .

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Key information

Conditions

Cerebral Hypoxia Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Hypoxia Hypoxia, Brain Mental Disorders Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Cognitive Dysfunction Postoperative Complications Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital of Sun YetSen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Procedure

use total intravenous anesthesia with propofol

Sevoflurane

Procedure

use inhalation anesthesia with sevoflurane

Primary outcomes

  1. the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia

    Time frame: 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 outcomes

  1. the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia

    Time frame: 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.

  2. 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

  3. the Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia

    Time frame: before anesthesia,after extubation,1 day after operation

Other outcomes

  1. Vital Signs

    Time frame: baseline , evey hour in the operation,afte extubation

    heart rate, artery blood pressure,pulse oxygen saturation,temperature

  2. Blood Gas Analysis

    Time frame: baseline,every hour in the operation,after extubation

    including artery blood and blood from jugular vein bulb

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Dec 31, 2012
Registry last updated
Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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