The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane

NCT01757561 | Completed Results DMC

• 1 other identifier: 伦审[2012]324号
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Hypoxia; Postoperative Cognitive Dysfunction

Keywords

jugular bulb oxygen saturation; postoperative cognitive dysfunction; propofol; sevoflurane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  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 Outcomes (2)

• Vital Signs

  baseline , evey hour in the operation,afte extubation

• Blood Gas Analysis

  baseline,every hour in the operation,after extubation

Study Arms (4)

Propofol-Abnormal

patients with preoperative SjvO2\<55%,using the TIVA technology with propofol,

Procedure: propofol

Propofol-Normal

patients with preoperative SjvO2≥55%,using the TIVA technology with propofol,

Procedure: propofol

Sevoflurane-Abnormal

patients with preoperative SjvO2\<55%,using the VIMA technology with sevoflurane,

Procedure: sevoflurane

Sevoflurane-Normal

patients with preoperative SjvO2≥55%,using the VIMA technology with sevoflurane,

Procedure: sevoflurane

Interventions

propofol PROCEDURE

use total intravenous anesthesia with propofol

Propofol-Abnormal; Propofol-Normal

sevoflurane PROCEDURE

use inhalation anesthesia with sevoflurane

Sevoflurane-Abnormal; Sevoflurane-Normal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing elective major surgery

You may qualify if:

• scheduled to take major surgery under general anesthesia over 18 years old classified as ASA class three or less

You may not qualify if:

• have a diagnosis of cerebrovascular disorder

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

the First Affiliated Hospital of Sun YetSen University

Guangzhou, Guangdong, 510080, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Hypoxia, Brain; Postoperative Cognitive Complications

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Results Point of Contact

• Title: Juan-ying Guo
• Organization: FirstSunYetSen

gjunying@aliyun.com

8602087755766(8273)

Study Officials

• Guo J Ying, Master

  the First Affiliated Hospital of SunYetSen University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 31, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: September 18, 2015
• Results First Posted: September 18, 2015

Record last verified: 2015-08

Locations

CN (1)