Intracranial NeurosurgeryNCT01200433
The Effects of Dexmedetomidine and Propofol on Cerebral Blood Flow and Brain Oxygenation During Deep Brain Stimulation
A study testing dexmedetomidine and propofol in people with Intracranial Neurosurgery, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The investigators will evaluate the effects of dexmedetomidine and propofol on cerebral blood flow and brain oxygenation during Deep Brain Stimulation (DBS) surgery. Specifically, the investigators will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Neurosurgery
- What is being tested?
- dexmedetomidine and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III.
- Scheduled for DBS.
Who cannot join
- History of dystonia.
- Severe heart failure with ejection fraction less than 30%.
- History of obstructive sleep apnea.
- History of renal failure with creatinine level > 2 mg/dl.
- Allergies to α-2 agonists and propofol.
- Current use of α-2 agonist medications such as clonidine.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will evaluate the effects of dexmedetomidine and propofol on cerebral blood flow and brain oxygenation during Deep Brain Stimulation (DBS) surgery. Specifically, the investigators will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.
- Conditions
- Intracranial Neurosurgery
- Being tested
- dexmedetomidine, propofol
- Keywords
- dexmedetomidine, propofol, cerebral blood flow, brain oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
Also called Precedex
Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.
propofolDrug
Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | Subjects will be sedated with propofol. Receives: Drug: propofol |
| dexmedetomidine | Active comparator | Subjects will be sedated with dexmedetomidine. Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Blood Flow
Cerebral blood flow was the average of right and left carotid velocities recorded by transcranial Doppler.
Measured: For patients randomized to dexmedetomidine: at the first peak of study drug (i.e., at peak dose of study drug during first infusion period); for patients randomized to propofol: when infusion of propofol stopped.
Brain Oxygen
Brain oxygenation values were estimated by near-infrared spectroscopy and brain oxygenation was averaged across the first and second study drug infusion periods.
Measured: during first (10-20 minutes) and second (throughout the procedure) study drug infusion periods
Secondary outcomes (6)
Cerebral Blood Flow
The investigator will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.
Measured: after procedure, in post anesthesia care unit (PACU)
Alertness/Sedation
Modified observer's assessment of alertness /sedation (OAA/S) scale which ranges from 0 to 5 (0 = does not respond to noxious stimuli and 5 = responds to name spoken in normal tone)
Measured: at the first peak during DBS surgery
Pulsatility Index
Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and minimum diastolic velocities divided by the mean velocity during the cardiac cycle.
Measured: at the first peak during DBS surgery
Cerebral Perfusion Pressure
Measured: at the first peak during DBS surgery
Number of Hypertensive Episodes
The number of hypertensive episodes during Deep Brain Stimulation (DBS) surgery.
Measured: During DBS surgery
Number of Apneic Episodes.
The number of antihypertensive interventions during Deep Brain Stimulation (DBS) surgery.
Measured: during DBS surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2013
- Study completionAug 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial NeurosurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Farag, The Cleveland Clinic
- Investigators
- Ehab Farag, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200433
- Sponsor's protocol ID
- 10-715
- Status last verified
- Oct 2016
- First submitted
- 10 Sep 2010
- Last updated
- 14 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Farag E, Kot M, Podolyak A, Argalious M, Deogaonkar M, Mascha EJ, Xu Z, Katzan I, Ebrahim Z. The relative effects of dexmedetomidine and propofol on cerebral blood flow velocity and regional brain oxygenation: A randomised noninferiority trial. Eur J Anaesthesiol. 2017 Nov;34(11):732-739. doi: 10.1097/EJA.0000000000000662.
PubMed 28891839
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dexmedetomidine and Propofol on Cerebral Blood Flow and Brain Oxygenation During Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT01200433
- Acronym / sponsor ID
- 10-715
- Conditions
- Intracranial Neurosurgery
- Keywords
- dexmedetomidine, propofol, cerebral blood flow, brain oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Posted 13 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will evaluate the effects of dexmedetomidine and propofol on cerebral blood flow and brain oxygenation during Deep Brain Stimulation (DBS) surgery. Specifically, the investigators will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: propofolSubjects will be sedated with propofol. |
| dexmedetomidine | Active comparator | Drug: dexmedetomidineSubjects will be sedated with dexmedetomidine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-III.
- Scheduled for DBS.
Key exclusion criteria (6 listed)
- History of dystonia.
- Severe heart failure with ejection fraction less than 30%.
- History of obstructive sleep apnea.
- History of renal failure with creatinine level > 2 mg/dl.
- Allergies to α-2 agonists and propofol.
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 |
|---|---|---|
| dexmedetomidineAlso: PrecedexPatients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure. | Drug | dexmedetomidine |
| propofolPatients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response | Drug | propofol |
Primary outcome
Cerebral Blood Flow
Time frame: For patients randomized to dexmedetomidine: at the first peak of study drug (i.e., at peak dose of study drug during first infusion period); for patients randomized to propofol: when infusion of propofol stopped.
Cerebral blood flow was the average of right and left carotid velocities recorded by transcranial Doppler.
Brain Oxygen
Time frame: during first (10-20 minutes) and second (throughout the procedure) study drug infusion periods
Brain oxygenation values were estimated by near-infrared spectroscopy and brain oxygenation was averaged across the first and second study drug infusion periods.
6 secondary outcomes
Cerebral Blood Flow
Time frame: after procedure, in post anesthesia care unit (PACU)
Alertness/Sedation
Time frame: at the first peak during DBS surgery
Pulsatility Index
Time frame: at the first peak during DBS surgery
Cerebral Perfusion Pressure
Time frame: at the first peak during DBS surgery
Number of Hypertensive Episodes
Time frame: During DBS surgery
Number of Apneic Episodes.
Time frame: during DBS surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28891839Farag E, Kot M, Podolyak A, Argalious M, Deogaonkar M, Mascha EJ, Xu Z, Katzan I, Ebrahim Z. The relative effects of dexmedetomidine and propofol on cerebral blood flow velocity and regional brain oxygenation: A randomised noninferiority trial. Eur J Anaesthesiol. 2017 Nov;34(11):732-739. doi: 10.1097/EJA.0000000000000662.
- Individual participant dataSharing planned: No
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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.
Ehab Farag, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine and propofol in people with Intracranial Neurosurgery, run by The Cleveland Clinic at 1 site in United States.
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 2 inclusion and 6 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 14 Dec 2016. 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 United States. 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 13 Jun 2016). 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?
Cerebral Blood Flow (time frame: For patients randomized to dexmedetomidine: at the first peak of study drug (i.e., at peak dose of study drug during first infusion period); for patients randomized to propofol: when infusion of propofol stopped.). The study lists 2 primary outcomes in all. 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 NCT01200433, which also lists 1 linked publication.
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 14 Dec 2016.