Cerebral IschemiaNCT01436799

Desflurane Versus Propofol in the Sitting Position

A study testing propofol, Desflurane and alfentanil in people with Cerebral Ischemia, run by Gachon University Gil Medical Center.

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 investigators hypothesized that both propofol and desflurane would decrease the regional oxygen saturation (rSO2) but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position. Read more about this study

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Cerebral Ischemia
What is being tested?: propofol, Desflurane and alfentanil
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: No sites listed yet
Study dates: Mar 2011to Aug 2011
Phase: Interventional
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 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Forty patients,
ASA class I or II,
undergoing shoulder arthroscopy

Who cannot join

Patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index > 30) were excluded from this study.

About this study

Official title: International Review Board of Gachon University Gil Hospital

Read the detailed description

The investigators hypothesized that both propofol and desflurane would decrease the rSO2 but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position. Therefore, the purpose of this study was to investigate the effect of desflurane and propofol on rSO2 values during the beach chair position for shoulder arthroscopy.

Conditions: Cerebral Ischemia
Being tested: propofol, Desflurane, alfentanil, Rocuronium
Keywords: propofol, desflurane, cerebrovascular circulation, sitting
Medical subject headings: Brain Ischemia

What participants receive

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

propofolDrug
anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1 mainly.
DesfluraneDrug
Also called Des
anaesthesia was maintained by desflurane 4-7vol%
alfentanilDrug
Also called alf
administration of alfentanil 10 μg kg-1 for anesthetic induction
RocuroniumDrug
Also called roc
administration of rocuronium 0.6 mg kg-1 for anesthetic induction

Study groups in NCT01436799
Study group	Role	What they receive
Desflurane	Experimental	anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane Receives: Drug: Desflurane; Drug: alfentanil; Drug: Rocuronium
propofol	Active comparator	anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model Receives: Drug: propofol; Drug: alfentanil; Drug: Rocuronium

What is being measured

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

Regional Cerebral Oxygen Satuation (rSO2)
definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD)
Measured: 1, 3, 5, 7, and 9 min after the beach chair position

Timeline

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

Mar 2011Aug 2011

First posted20 Sep 2011 (estimated)
Study startMar 2011
Primary completionAug 2011
Study completionAug 2011

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 IschemiaStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01436799
Sponsor's protocol ID: GIRBA2466
Status last verified: Aug 2013
First submitted: 15 Sep 2011
Last updated: 9 Sep 2013
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?

Official record

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All Cerebral Ischemia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: International Review Board of Gachon University Gil Hospital
ClinicalTrials.gov ID: NCT01436799
Acronym / sponsor ID: GIRBA2466
Conditions: Cerebral Ischemia
Keywords: propofol, desflurane, cerebrovascular circulation, sitting
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Gachon University Gil Medical CenterUniversity, hospital or other
Study start: Mar 2011
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 20 Sep 2011 (estimated)
Results: Posted 26 Aug 2013

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Desflurane	Experimental	Drug: Desflurane, Drug: alfentanil, Drug: Rocuroniumanaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
propofol	Active comparator	Drug: propofol, Drug: alfentanil, Drug: Rocuroniumanaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Forty patients,
ASA class I or II,
undergoing shoulder arthroscopy

Key exclusion criteria (1 listed)

Patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index > 30) were excluded from this study.

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
propofolanaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1 mainly.	Drug	propofol
DesfluraneAlso: Desanaesthesia was maintained by desflurane 4-7vol%	Drug	Desflurane
alfentanilAlso: alfadministration of alfentanil 10 μg kg-1 for anesthetic induction	Drug	Desflurane, propofol
RocuroniumAlso: rocadministration of rocuronium 0.6 mg kg-1 for anesthetic induction	Drug	Desflurane, propofol

Primary outcome

Regional Cerebral Oxygen Satuation (rSO2)
Time frame: 1, 3, 5, 7, and 9 min after the beach chair position
definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD)

Results and safety

Results posted to the registry on 26 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Desflurane	20	20
Propofol	20	20

Primary outcome: Regional Cerebral Oxygen Satuation (rSO2)

Time frame: 1, 3, 5, 7, and 9 min after the beach chair position. Mean (Standard Deviation). Unit: percentage of rSO2 (%)

Measure	Desflurane n = 20	Propofol n = 20
1min after beach chair position	77.4 (7)	72.5 (9.5)
3min after beach chair position	76 (7.1)	70 (9.8)
5min after beach chair position	75.2 (7.4)	70 (8.5)
7min after beach chair position	75.1 (7.2)	68.5 (10.1)
9min after beach chair position	74 (7.8)	67.8 (9.8)

Population analysed: A power analysis was calculated based on a previous study.14 In each group, 16 patients were needed to detect a mean intergroup difference of 5% in the rSO2 value with a power of 80% and a type I error of 0.05. To compensate for a dropout rate of 20%, 40 patients were included in this study.

Adverse events

Time frame: 1, 3, 5, 7 and 9 min after the sitting position and postoperative 24hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Desflurane	0 of 20 (0%)	0 of 20 (0%)	Not reported
Propofol	0 of 20 (0%)	0 of 20 (0%)	Not reported

Limitations and caveats (from the sponsor): limitations of this study is that the ventilation was adjusted according to ETCO2 value instead of the arterial carbon dioxide tensions (PaCO2).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
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.

Hyun Jeong Kwak, MD.PhD study director

Gachon University Gil Medical Center

Questions about this trial

What is this clinical trial studying?

A study testing propofol, Desflurane and alfentanil in people with Cerebral Ischemia, run by Gachon University Gil Medical Center.

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 3 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 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

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 26 Aug 2013). 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?

Regional Cerebral Oxygen Satuation (rSO2) (time frame: 1, 3, 5, 7, and 9 min after the beach chair position). 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 NCT01436799.

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 9 Sep 2013.