Trial Outcomes & Findings for Deep Brain Stimulation (DBS) Sedation (NCT NCT03283150)

Last Updated: 2024-07-05

Results Overview

Effects of propofol, remifentanil and dexmedetomidine on the neuronal activity during microelectrode recording (MER) in different brain structures that are used as target for DBS implantation will be measure. The RMS of the electrical activity as a measure of the spiking rate of neurons in the vicinity of the electrode tip. normalize the RMS to the baseline value recorded at the first 2-5 minutes of MER (before entering the target area) to compensate for differences between patients and recording electrodes. In order to calculate the change in the normalized RMS following sedation the investigators will compare the mean RMS during 2 minutes of the stable recording of the pre-sedation baseline to the mean RMS during stable sedation and following recovery.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

45 minutes

Results posted on

2024-07-05

Participant Flow

Participant milestones

Participant milestones
Measure	Remifentanil Remifentanil will be administered to subjects during microelectrode recordings (MER). Remifentanil: Remifentanyl will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the bispectral index (BIS) values to normalize to awake level for the MER.	Propofol Propofol will be administered to subjects during MER. Propofol: Propofol will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.	Dexmedetomidine Dexmedetomidine will be administered to subjects during MER. Dexmedetomidine: Dexmedetomidine will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.
Overall Study STARTED	20	0	0
Overall Study COMPLETED	14	0	0
Overall Study NOT COMPLETED	6	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Remifentanil Remifentanil will be administered to subjects during microelectrode recordings (MER). Remifentanil: Remifentanyl will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the bispectral index (BIS) values to normalize to awake level for the MER.	Propofol Propofol will be administered to subjects during MER. Propofol: Propofol will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.	Dexmedetomidine Dexmedetomidine will be administered to subjects during MER. Dexmedetomidine: Dexmedetomidine will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.
Overall Study Withdrawal by Subject	6	0	0

Baseline Characteristics

Deep Brain Stimulation (DBS) Sedation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remifentanil n=20 Participants Remifentanil will be administered to subjects during microelectrode recordings (MER). Remifentanil: Remifentanyl will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.	Propofol Propofol will be administered to subjects during MER. Propofol: Propofol will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.	Dexmedetomidine Dexmedetomidine will be administered to subjects during MER. Dexmedetomidine: Dexmedetomidine will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.	Total n=20 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	—	—	60 years n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	—	—	5 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	—	—	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	—	—	18 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	—	—	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	—	—	18 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	—	—	2 Participants n=4 Participants
Region of Enrollment United States	20 participants n=5 Participants	—	—	20 participants n=4 Participants

PRIMARY outcome

Timeframe: 45 minutes

Population: No subjects were accrued into the propofol or dexmedetomidine groups as COVID-19 struck and the number of procedures performed decreased substantially during and post-COVID.

Outcome measures

Outcome measures
Measure	Remifentanil n=14 Participants Remifentanil will be administered to subjects during microelectrode recordings (MER). Remifentanil: Remifentanyl will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.	Propofol Propofol will be administered to subjects during MER. Propofol: Propofol will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.	Dexmedetomidine Dexmedetomidine will be administered to subjects during MER. Dexmedetomidine: Dexmedetomidine will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.
Sedatives Drugs Effects - Percent Change in Root Mean Square (RMS) of Electrical Activity	2.69 percent change Standard Deviation 0.37	—	—

SECONDARY outcome

Timeframe: up to 57 minutes

Population: No subjects were accrued to the propofol or dexmedetomidine groups.

This outocme meadsures the mean time from sedation to recovery.

Outcome measures

Outcome measures
Measure	Remifentanil n=14 Participants Remifentanil will be administered to subjects during microelectrode recordings (MER). Remifentanil: Remifentanyl will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.	Propofol Propofol will be administered to subjects during MER. Propofol: Propofol will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.	Dexmedetomidine Dexmedetomidine will be administered to subjects during MER. Dexmedetomidine: Dexmedetomidine will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.
Mean Time in Minutes From Sedation to Recovery	29.43 minutes Interval 11.0 to 57.0	—	—

SECONDARY outcome

Timeframe: 1hrs 30 min

Population: No subjects were accrued to the propofol or dexmedetomidine groups due to COVID and the decrease in the frequency of the surgery being performed at the hospital.

The number of subjects examining the neuronal activity changes at multiple brain regions under the effect of different sedation drugs to enable further study of the effects of anesthetics on brain regions and the mechanisms underlying loss of consciousness.

Outcome measures

Outcome measures
Measure	Remifentanil n=14 Participants Remifentanil will be administered to subjects during microelectrode recordings (MER). Remifentanil: Remifentanyl will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.	Propofol Propofol will be administered to subjects during MER. Propofol: Propofol will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.	Dexmedetomidine Dexmedetomidine will be administered to subjects during MER. Dexmedetomidine: Dexmedetomidine will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.
Number of Individuals Examined for Neuronal Activity Changes at Multiple Brain Regions Under the Effect of Different Sedative Drugs	14 Participants	0 Participants	0 Participants

Adverse Events

Remifentanil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeremy Sullivan

University of Wisconsin-Madison

Phone: 6082639976

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place