Cerebral HypoxiaNCT01757561

The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane

An observational study of Cerebral Hypoxia and Postoperative Cognitive Dysfunction, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Cerebral Hypoxia, Postoperative Cognitive Dysfunction
What is being tested?: propofol and sevoflurane
Type of treatment: Injection or infusion, Surgery or procedure
How many people: 144 participants
Where: 1 siteChina
Study dates: Dec 2012to Mar 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult patients undergoing elective major surgery

Who may be able to join

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

Who cannot join

have a diagnosis of cerebrovascular disorder

Trial locations and contacts

1 site in 1 country.

China1 site

the First Affiliated Hospital of Sun YetSen University
Guangzhou, Guangdong, 510080

Other trials in China

About this study

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.

Conditions: Cerebral Hypoxia, Postoperative Cognitive Dysfunction
Being tested: propofol, sevoflurane
Keywords: jugular bulb oxygen saturation, postoperative cognitive dysfunction, propofol, sevoflurane
Medical subject headings: Hypoxia, Brain, Postoperative Cognitive Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

propofolProcedure or surgery
use total intravenous anesthesia with propofol
sevofluraneProcedure or surgery
use inhalation anesthesia with sevoflurane

Study groups in NCT01757561
Study group	Role	What they receive
Propofol-Abnormal		patients with preoperative SjvO2<55%,using the TIVA technology with propofol, Receives: Procedure: propofol
Propofol-Normal		patients with preoperative SjvO2≥55%,using the TIVA technology with propofol, Receives: Procedure: propofol
Sevoflurane-Abnormal		patients with preoperative SjvO2<55%,using the VIMA technology with sevoflurane, Receives: Procedure: sevoflurane
Sevoflurane-Normal		patients with preoperative SjvO2≥55%,using the VIMA technology with sevoflurane, Receives: Procedure: sevoflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

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%.
Measured: 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
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.
Measured: 1-3days、5-7days after operation
the Change in the Level of Serum BDNF(Brain-derived Neurotrophic Factor ) Between Propofol and Sevoflurane Anesthesia
Measured: before anesthesia, after extubation ,1day after operation
the Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia
Measured: before anesthesia,after extubation,1 day after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Mar 2014

First posted31 Dec 2012 (estimated)
Study startDec 2012
Primary completionDec 2013
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cerebral HypoxiaStudies of the same condition, open and under way.
More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01757561
Sponsor's protocol ID: 伦审[2012]324号
Status last verified: Aug 2015
First submitted: 18 Dec 2012
Last updated: 18 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebral Hypoxia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane
ClinicalTrials.gov ID: NCT01757561
Acronym / sponsor ID: 伦审[2012]324号
Conditions: Cerebral Hypoxia, Postoperative Cognitive Dysfunction
Keywords: jugular bulb oxygen saturation, postoperative cognitive dysfunction, propofol, sevoflurane
Study type: Observational
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
Study start: Dec 2012
Primary completion: Dec 2013 (actual)
Study completion: Mar 2014 (actual)
First posted: 31 Dec 2012 (estimated)
Results: Posted 18 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
Propofol-Abnormal	–	Procedure: propofolpatients with preoperative SjvO2<55%,using the TIVA technology with propofol,
Propofol-Normal	–	Procedure: propofolpatients with preoperative SjvO2≥55%,using the TIVA technology with propofol,
Sevoflurane-Abnormal	–	Procedure: sevofluranepatients with preoperative SjvO2<55%,using the VIMA technology with sevoflurane,
Sevoflurane-Normal	–	Procedure: sevofluranepatients with preoperative SjvO2≥55%,using the VIMA technology with sevoflurane,

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients undergoing elective major surgery

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

have a diagnosis of cerebrovascular disorder

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
propofoluse total intravenous anesthesia with propofol	Procedure or surgery	Propofol-Abnormal, Propofol-Normal
sevofluraneuse inhalation anesthesia with sevoflurane	Procedure or surgery	Sevoflurane-Abnormal, Sevoflurane-Normal

Primary outcome

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%.

3 secondary outcomes

the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia
Time frame: 1-3days、5-7days after operation
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
the Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia
Time frame: before anesthesia,after extubation,1 day after operation

Results and safety

Results posted to the registry on 18 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Propofol-Abnormal	38	32
Propofol-Normal	34	28
Sevoflurane-Abnormal	38	31
Sevoflurane-Normal	34	25

Primary outcome: the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia

Time frame: baseline ,every hour in the operation period,after extubation. Number. Unit: participants

Measure	Propofol-Abnormal n = 32	Propofol-Normal n = 28	Sevoflurane-Abnormal n = 31	Sevoflurane-Normal n = 25
Value	17	6	6	0

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: the day of surgery and 1 week after surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Propofol-Abnormal	0 of 38 (0%)	1 of 38 (2.6%)	Not reported
Propofol-Normal	0 of 34 (0%)	0 of 34 (0%)	Not reported
Sevoflurane-Abnormal	0 of 38 (0%)	0 of 38 (0%)	Not reported
Sevoflurane-Normal	0 of 34 (0%)	2 of 34 (5.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Guo J Ying, Master study chair

the First Affiliated Hospital of SunYetSen University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Hypoxia and Postoperative Cognitive Dysfunction, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia (time frame: baseline ,every hour in the operation period,after extubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01757561.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.