BACKGROUND:Dexmedetomidine constricts cerebral blood vessels without a concomitant reduction in cerebral metabolic oxygen consumption. Its safety as a sedative in patients with neurological diseases thus remains uncertain. OBJECTIVE: Our primary objective was to test the hypothesis that dexmedetomidine is noninferior to propofol as regards cerebral blood flow (CBF) velocity and brain oxygenation. DESIGN: Unblinded randomised trial. SETTING: Cleveland Clinic Hospital, Cleveland, from November 2010 to July 2013. PATIENTS: Forty-four patients scheduled for insertion of a deep-brain stimulating electrodes. INTERVENTIONS: Patients were randomised to receive either dexmedetomidine or propofol sedation during deep-brain stimulating electrode insertion. MAIN OUTCOME MEASURES: Intraoperative CBF velocity was measured with transcranial Doppler, and brain oxygenation was assessed with near-infrared spectroscopy. Noninferiority of dexmedetomidine to propofol was defined as a less than 20% difference in means. RESULTS: Twenty-three patients were given dexmedetomidine and 21 propofol. Baseline characteristics and operative management were similar in each group. Dexmedetomidine was noninferior to propofol on both CBF and brain oxygenation, confirming our primary hypothesis. For cerebral flood flow, the estimated ratio of means (dexmedetomidine/propofol) was 0.94 [90% CI: 0.84 to 1.05], P = 0.011 for noninferiority. For brain oxygenation, the estimated ratio of means was 0.99 [90% CI: 0.96 to 1.02], P < 0.001 for noninferiority. Superiority was not found for either primary outcome. Dexmedetomidine provided deeper sedation than propofol, with a difference of medians of 1 [90% CI: 0 to 2], P < 0.001 on the Observer's Assessment of Alertness/Sedation scale. No significant differences were observed in pulsatility index, cerebral perfusion pressure, number of hypertensive or apnoeic episodes. CONCLUSION:Regional brain oxygenation and CBF velocity are comparably preserved during dexmedetomidine and propofolsedation. Thus, the use of dexmedetomidine in patients with movement disorders appears reasonable. TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov (NCT 01200433).
RCT Entities:
BACKGROUND:Dexmedetomidine constricts cerebral blood vessels without a concomitant reduction in cerebral metabolic oxygen consumption. Its safety as a sedative in patients with neurological diseases thus remains uncertain. OBJECTIVE: Our primary objective was to test the hypothesis that dexmedetomidine is noninferior to propofol as regards cerebral blood flow (CBF) velocity and brain oxygenation. DESIGN: Unblinded randomised trial. SETTING: Cleveland Clinic Hospital, Cleveland, from November 2010 to July 2013. PATIENTS: Forty-four patients scheduled for insertion of a deep-brain stimulating electrodes. INTERVENTIONS:Patients were randomised to receive either dexmedetomidine or propofol sedation during deep-brain stimulating electrode insertion. MAIN OUTCOME MEASURES: Intraoperative CBF velocity was measured with transcranial Doppler, and brain oxygenation was assessed with near-infrared spectroscopy. Noninferiority of dexmedetomidine to propofol was defined as a less than 20% difference in means. RESULTS: Twenty-three patients were given dexmedetomidine and 21 propofol. Baseline characteristics and operative management were similar in each group. Dexmedetomidine was noninferior to propofol on both CBF and brain oxygenation, confirming our primary hypothesis. For cerebral flood flow, the estimated ratio of means (dexmedetomidine/propofol) was 0.94 [90% CI: 0.84 to 1.05], P = 0.011 for noninferiority. For brain oxygenation, the estimated ratio of means was 0.99 [90% CI: 0.96 to 1.02], P < 0.001 for noninferiority. Superiority was not found for either primary outcome. Dexmedetomidine provided deeper sedation than propofol, with a difference of medians of 1 [90% CI: 0 to 2], P < 0.001 on the Observer's Assessment of Alertness/Sedation scale. No significant differences were observed in pulsatility index, cerebral perfusion pressure, number of hypertensive or apnoeic episodes. CONCLUSION: Regional brain oxygenation and CBF velocity are comparably preserved during dexmedetomidine and propofol sedation. Thus, the use of dexmedetomidine in patients with movement disorders appears reasonable. TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov (NCT 01200433).
Authors: Tao Liu; Fang-Chao Liu; Yu Xia; Tai-Jun Luo; Fei Wang; Bin Chen; Chun Wang; Guang-Kuo Gao; Wen-Ting Zhai; Wei Liu Journal: J Int Med Res Date: 2022-09 Impact factor: 1.573