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CompletedNCT01757561Updated Sep 18, 2015Results posted

The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane

An observational study in Cerebral Hypoxia and Postoperative Cognitive Dysfunction, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-18.

Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
144
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cerebral Hypoxia
  • Postoperative Cognitive Dysfunction

Keywords

  • jugular bulb oxygen saturation
  • postoperative cognitive dysfunction
  • propofol
  • sevoflurane
03

In context

Hypoxia, Brain

78 studies on the registry are indexed under Hypoxia, Brain; 21 are open to participants now.

This study's enrollment of 144 is above the median of 50 across 23 observational studies indexed under Hypoxia, Brain.

Browse Hypoxia, Brain studies →

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients undergoing elective major surgery

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • have a diagnosis of cerebrovascular disorder
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
144 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Procedurepropofol

    use total intravenous anesthesia with propofol

  • Proceduresevoflurane

    use inhalation anesthesia with sevoflurane

06

What researchers measure

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%.

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

Secondary outcomes

  1. 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.

    Time frame: 1-3days、5-7days after operation

  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

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

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

  2. Blood Gas Analysis

    including artery blood and blood from jugular vein bulb

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

07

Results

Posted Sep 18, 2015

Participant flow

Participant flow — Overall Study
MilestonePropofol-AbnormalPropofol-NormalSevoflurane-AbnormalSevoflurane-Normal
Started38343834
Completed32283125
Not completed6679

Outcome measures

Primarythe 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%.

Time frame:
baseline ,every hour in the operation period,after extubation
Reported as:
Number · participants
the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia
participantsPropofol-AbnormalPropofol-NormalSevoflurane-AbnormalSevoflurane-Normal
the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia17660
Secondarythe 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.

Time frame:
1-3days、5-7days after operation
Reported as:
Number · participants
the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia
participantsPropofol-AbnormalPropofol-NormalSevoflurane-AbnormalSevoflurane-Normal
1--3days after operation9448
5-7 days after operation5244
Secondarythe 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

Results for this outcome have not been posted.

Secondarythe Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia
Time frame:
before anesthesia,after extubation,1 day after operation

Results for this outcome have not been posted.

Other pre-specifiedVital Signs

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

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

Results for this outcome have not been posted.

Other pre-specifiedBlood Gas Analysis

including artery blood and blood from jugular vein bulb

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

Results for this outcome have not been posted.

Adverse events

Collected over the day of surgery and 1 week after surgery. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Propofol-Abnormal—0/38 (0%)1/38 (2.6%)
Propofol-Normal—0/34 (0%)0/34 (0%)
Sevoflurane-Abnormal—0/38 (0%)0/38 (0%)
Sevoflurane-Normal—0/34 (0%)2/34 (5.9%)
Most frequent serious events
Most frequent serious events
EventPropofol-AbnormalPropofol-NormalSevoflurane-AbnormalSevoflurane-Normal
heart failureCardiac disorders0/380/340/380/34
pulmonary edemaRespiratory, thoracic and mediastinal disorders0/380/340/380/34
Most frequent other events
Most frequent other events
EventPropofol-AbnormalPropofol-NormalSevoflurane-AbnormalSevoflurane-Normal
allergyImmune system disorders1/380/340/382/34

Baseline characteristics

Age, Continuous
Age, Continuous(years)Propofol-AbnormalPropofol-NormalSevoflurane-AbnormalSevoflurane-NormalTotal
Mean63.5 ± 7.669 ± 10.564.2 ± 8.367.2 ± 8.565.7 ± 8.6
Sex: Female, Male
Sex: Female, Male(Participants)Propofol-AbnormalPropofol-NormalSevoflurane-AbnormalSevoflurane-NormalTotal
Female9138838
Male2315231778
ASA
ASA(participants)Propofol-AbnormalPropofol-NormalSevoflurane-AbnormalSevoflurane-NormalTotal
ASAⅡ3022231792
ASA Ⅲ268824
08

Study locations

1 site
  • the First Affiliated Hospital of Sun YetSen University
    Guang Zhou, Guangdong 510080, China
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01757561
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Responsible party
Jun-ying Guo (Attending physician, First Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Dec 31, 2012
Start date
Dec 2012
Primary completion
Dec 2013
Completion
Mar 2014
Results posted
Sep 18, 2015
Last update
Sep 18, 2015

Study contacts

Guo J Ying, Master
study chair · the First Affiliated Hospital of SunYetSen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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