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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01757561
Other study ID # ??[2012]324?
Secondary ID
Status Completed
Phase N/A
First received December 18, 2012
Last updated August 18, 2015
Start date December 2012
Est. completion date March 2014

Study information

Verified date August 2015
Source First Affiliated Hospital, Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date March 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
propofol
use total intravenous anesthesia with propofol
sevoflurane
use inhalation anesthesia with sevoflurane

Locations

Country Name City State
China the First Affiliated Hospital of Sun YetSen University Guang Zhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Vital Signs heart rate, artery blood pressure,pulse oxygen saturation,temperature baseline , evey hour in the operation,afte extubation No
Other Blood Gas Analysis including artery blood and blood from jugular vein bulb baseline,every hour in the operation,after extubation No
Primary 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 No
Secondary 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 No
Secondary the Change in the Level of Serum BDNF(Brain-derived Neurotrophic Factor ) Between Propofol and Sevoflurane Anesthesia before anesthesia, after extubation ,1day after operation No
Secondary the Change in the Level of Serum s-100ß Between Propofol and Sevoflurane Anesthesia before anesthesia,after extubation,1 day after operation No
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