Trial Outcomes & Findings for Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine (NCT NCT00671931)

NCT ID: NCT00671931

Last Updated: 2013-08-23

Results Overview

The primary outcome measure of the study was the participants who had Motor Evoked Potentials Amplitude significantly reduced (more than 70%)compared to the baseline.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

44 participants

Primary outcome timeframe

baseline, 30 minutes

Results posted on

2013-08-23

Participant Flow

Enrollment has been completed for this study.

There is no wash out, run-in, or transition period in this protocol

Participant milestones

Participant milestones
Measure	Low Dexmedetomidine/Low Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75	High Dexmedetomidine/Low Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75	Low Dexmedetomidine/High Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75	High Dexmedetomidine/High Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75	Intermediate Dexmedetomidine/Intermediate Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75
Overall Study STARTED	9	8	9	10	8
Overall Study COMPLETED	8	8	9	8	7
Overall Study NOT COMPLETED	1	0	0	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Low Dexmedetomidine/Low Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75	High Dexmedetomidine/Low Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75	Low Dexmedetomidine/High Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75	High Dexmedetomidine/High Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75	Intermediate Dexmedetomidine/Intermediate Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75
Overall Study Physician Decision	1	0	0	2	1

Baseline Characteristics

Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dexmedetomidine/Low Propofol n=9 Participants Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75	High Dexmedetomidine/Low Propofol n=8 Participants Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75	Low Dexmedetomidine/High Propofol n=9 Participants Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75	High Dexmedetomidine/High Propofol n=10 Participants Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75	Intermediate Dexmedetomidine/Intermediate Propofol n=8 Participants Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2. TABLE 2: dexmedetomidine and propofol dose schedule. Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\\ ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	8 Participants n=21 Participants	43 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age Continuous	16 years STANDARD_DEVIATION 2 • n=5 Participants	15 years STANDARD_DEVIATION 2 • n=7 Participants	15 years STANDARD_DEVIATION 2 • n=5 Participants	15 years STANDARD_DEVIATION 2 • n=4 Participants	15 years STANDARD_DEVIATION 2 • n=21 Participants	15 years STANDARD_DEVIATION 2 • n=8 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	7 Participants n=21 Participants	35 Participants n=8 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	9 Participants n=8 Participants
Region of Enrollment United States	9 participants n=5 Participants	8 participants n=7 Participants	9 participants n=5 Participants	10 participants n=4 Participants	8 participants n=21 Participants	44 participants n=8 Participants

PRIMARY outcome

Timeframe: baseline, 30 minutes

The primary outcome measure of the study was the participants who had Motor Evoked Potentials Amplitude significantly reduced (more than 70%)compared to the baseline.