Trial Outcomes & Findings for Effects of Two Different Sedation Regimes on Auditory Evoked Potentials and Electroencephalogram (EEG) (NCT NCT00641563)

Results Overview

Event Related Potentials (time-locked amplitudes in the electroencephalogram 100 milliseconds after the acoustic stimulus, averaged over 40 stimuli) Sedation levels were graded with the Ramsay scale (RS), where the responses of patients to standardized increasing stimuli (voice, then prodding, the pain stimulus) are graded. The higher the number, the deeper is the sedation. RS 6 means no response at all (= anesthesia)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

awake + 3 sedation levels (RS2/3/4) (20 minutes each)

Results posted on

2011-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Dex/Remi Followed by Mida/Remi Sedation with dexmedetomidine and remifentanil followed by sedation with midazolam and remifentanil separated by one week	Mida/Remi Followed by Dex/Remi Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week
Infusion 1 STARTED	5	5
Infusion 1 COMPLETED	5	5
Infusion 1 NOT COMPLETED	0	0
Infusion 2 STARTED	5	5
Infusion 2 COMPLETED	5	5
Infusion 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Two Different Sedation Regimes on Auditory Evoked Potentials and Electroencephalogram (EEG)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=10 Participants Both arms combined
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	24 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment Switzerland	10 participants n=5 Participants

PRIMARY outcome

Timeframe: awake + 3 sedation levels (RS2/3/4) (20 minutes each)

Event Related Potentials (time-locked amplitudes in the electroencephalogram 100 milliseconds after the acoustic stimulus, averaged over 40 stimuli) Sedation levels were graded with the Ramsay scale (RS), where the responses of patients to standardized increasing stimuli (voice, then prodding, the pain stimulus) are graded. The higher the number, the deeper is the sedation. RS 6 means no response at all (= anesthesia)

Outcome measures

Outcome measures
Measure	Dex/Remi n=10 Participants Sedation with dexmedetomidine and remifentanil	Mida/Remi n=10 Participants Sedation with midazolam and remifentanil
Amplitudes (in Micro Volts) of Acoustic Event Related Potentials (Time-locked Amplitudes in the Electroencephalogram 100 Milliseconds After the Acoustic Stimulus, Averaged Over 40 Stimuli)Awake and at 3 Different Drug-induced Sedation Levels awake	-5.9 micro Volt Standard Deviation 1.3	-5.3 micro Volt Standard Deviation 1.3
Amplitudes (in Micro Volts) of Acoustic Event Related Potentials (Time-locked Amplitudes in the Electroencephalogram 100 Milliseconds After the Acoustic Stimulus, Averaged Over 40 Stimuli)Awake and at 3 Different Drug-induced Sedation Levels RS 2	-6.4 micro Volt Standard Deviation 1.1	-4.8 micro Volt Standard Deviation 2
Amplitudes (in Micro Volts) of Acoustic Event Related Potentials (Time-locked Amplitudes in the Electroencephalogram 100 Milliseconds After the Acoustic Stimulus, Averaged Over 40 Stimuli)Awake and at 3 Different Drug-induced Sedation Levels RS 3	-4.7 micro Volt Standard Deviation 2.4	-2.4 micro Volt Standard Deviation 2
Amplitudes (in Micro Volts) of Acoustic Event Related Potentials (Time-locked Amplitudes in the Electroencephalogram 100 Milliseconds After the Acoustic Stimulus, Averaged Over 40 Stimuli)Awake and at 3 Different Drug-induced Sedation Levels RS 4	-3.5 micro Volt Standard Deviation 2.7	-0.4 micro Volt Standard Deviation 1.1

SECONDARY outcome

Timeframe: awake and 3 sedation levels (RS 2/3/4) 20 min each

BIS-Index is a dimensionless value ranging from 0-100, indicating fully awake at 100 and a flat-line electroencephalogram at 0. Standard anesthesia creates a BIS-Index range 40-60. The scale is ordinal, not interval. BIS Index is calculated from the EEG by a proprietary algorithm (Aspect Medical Inc.)

Outcome measures

Outcome measures
Measure	Dex/Remi n=10 Participants Sedation with dexmedetomidine and remifentanil	Mida/Remi n=10 Participants Sedation with midazolam and remifentanil
BIS-Index Awake and 3 Sedation Levels (RS 2/3/4) awake	92.5 Units on a scale Standard Deviation 4.64	93.7 Units on a scale Standard Deviation 3.51
BIS-Index Awake and 3 Sedation Levels (RS 2/3/4) sedation level RS 2	84.5 Units on a scale Standard Deviation 5.82	84.7 Units on a scale Standard Deviation 5.13
BIS-Index Awake and 3 Sedation Levels (RS 2/3/4) sedation level RS 3	69.5 Units on a scale Standard Deviation 8.05	73.2 Units on a scale Standard Deviation 6.66
BIS-Index Awake and 3 Sedation Levels (RS 2/3/4) sedation level RS 4	51.4 Units on a scale Standard Deviation 7.16	68.9 Units on a scale Standard Deviation 5.70

Adverse Events

Dex/Remi

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mida/Remi Followed by Dex/Remi

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

Dr. M. Hänggi

University Hospital Bern, Switzerland

Phone: 0316323029

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place