The Effects of Dexmedetomidine and Propofol on Cerebral Blood Flow and Brain Oxygenation During Deep Brain Stimulation

Blood Flow Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01200433
• Other study ID #: 10-715
• Status: Active, not recruiting
• Phase: N/A
• First received: September 10, 2010
• Last updated: December 17, 2013
• Start date: October 2010
• Est. completion date: March 2014

Study information

• Verified date: October 2013
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• ASA I-III.

• Scheduled for DBS.

Exclusion Criteria:

• 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 a-2 agonists and propofol.

• Current use of a-2 agonist medications such as clonidine.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Blood Flow
• Brain Oxygenation
• Deep Brain Stimulation (DBS)

Intervention

Drug:
• dexmedetomidine
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.
• propofol
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

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebral blood flow	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.	few minutes before procedure	No
Primary	cerebral blood flow	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.	during procedure	No
Primary	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.	after procedure, in PACU	No
Secondary	alertness/sedation	Modified observer's assessment of alertness /sedation (OAA/S)	after sedation	No
Secondary	sub-thalamic nucleus (STN)	Recordings from the sub-thalamic nucleus (STN) and segment of the globus pallidum (GPi).	after sedation	No
Secondary	globus pallidum (GPi)	Recordings from the sub-thalamic nucleus (STN) and segment of the globus pallidum (GPi).	after sedation	No
Secondary	Arterial oxygen saturation	The number of antihypertensive interventions during Deep Brain Stimulation (DBS) insertion.	after sedation	No
Secondary	Number of apneic episodes.	The number of antihypertensive interventions during Deep Brain Stimulation (DBS) insertion.	after sedation	No