N/A
Completed N=44
The Effects of Dexmedetomidine and Propofol on Cerebral Blood Flow and Brain Oxygenation During Deep Brain Stimulation
Intracranial Neurosurgery
Source: ClinicalTrials.gov NCT01200433 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Cerebral Blood Flow — 45.4; 39.9 cm/sec — p=0.011
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cerebral Blood Flow |
55; 46.7 | — |
| PRIMARY Brain Oxygen |
73.5; 72.7 | < 0.001 sig |
| SECONDARY Cerebral Blood Flow |
55; 46.7 | — |
| SECONDARY Alertness/Sedation |
2; 3 | <0.001 sig |
| SECONDARY Pulsatility Index |
1; 1 | 0.91 |
| SECONDARY Cerebral Perfusion Pressure |
53.9; 54.6 | — |
| SECONDARY Number of Hypertensive Episodes |
4.9; 2.9 | 0.02 sig |
| SECONDARY Number of Apneic Episodes. |
0; 0 | >0.99 |
Eligibility Criteria
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 α-2 agonists and propofol.
- Current use of α-2 agonist medications such as clonidine.
Data sourced from ClinicalTrials.gov (NCT01200433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.