Dexmedetomidine vs Propofol on the Recordings of Deep Brain Activity Measured Through Implanted Stimulators

PHASE4CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Parkinson's Disease
Interventions
DRUG

Dexmedetomidine

Patients will receive a loading dose of 1 µg/kg in 10 min before starting the surgery. The maintenance dose will be 0.2-1 µg/kg/h for a Ramsey Sedation Score of 3-4 during the surgery´s preparation. It will be reduced to 0.2 µg/kg/h 15 min before starting the microelectrode recording for a Ramsey Sedation Score of 2. After the placement of the deep brain stimulator we will record the local field potentials activity. In addition, the subscales of rigidity, tremor and bradykinesia of the Unified Parkinson's Disease Rating Scale (UPDRS-III) score will be evaluated. Once the deep brain stimulator recording and neurologic exploration will be over patients will receive a maintenance dose 0.2-1 µg/kg/h until the end of the surgery. It will be stopped to transfer the patient to the ICU.

DRUG

Propofol

The target doses are 0.5, 1, 1.5, 2 and 2.5 µg/kg. For its administration we will use the TCI (target controlled infusion) system. After programming each dose we will wait until the plasma and brain concentration of propofol are stabilized in this target and then we will record the local field potentials activity through the DBS. In addition, the subscales of rigidity, tremor and bradykinesia of the UPDRS-III score will be evaluated.

Trial Locations (1)

31008

University of Navarra Clinic, Pamplona

All Listed Sponsors
lead

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

NCT02256319 - Dexmedetomidine vs Propofol on the Recordings of Deep Brain Activity Measured Through Implanted Stimulators | Biotech Hunter | Biotech Hunter