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

NCT00641563 | Completed Results

• 1 other identifier: KIM-NMP3
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Sedation may be necessary in intensive care to facilitate diverse therapeutic interventions, but the use of sedative drugs may increase the risk of delirium and long-term cognitive impairment. Thus the implementation and monitoring of sedation remains difficult despite the use of sedation protocols and clinical sedation scores. Attempts to improve sedation monitoring through the use of the electroencephalogram(EEG) have been disappointing. Derived variables based on the unstimulated EEG fail to predict the response to external stimuli at the clinically most relevant light-to-moderate sedation levels, and the overlap between moderate and deep sedation levels is wide. We have demonstrated that long-latency auditory evoked potentials (ERPs)can be used to avoid deep levels of sedation in healthy volunteers during propofol sedation, independent of the concomitant administration of remifentanil. This approach has a potential clinical application for improved monitoring of sedation. Since the effects of different sedative drugs on the EEG may vary widely, the use of ERPs to monitor sedation needs to be evaluated with different sedative drugs. Therefore we will administer two widely used drug combinations (dexmedetomidine/remifentanil and midazolam/remifentanil) in healthy volunteers and record ERPS and processed EEG during clinical relevant sedation levels

Conditions

Conscious Sedation; Deep Sedation; Critical Care

Keywords

dexmedetomidine; midazolam; remifentanil; Electroencephalography; Event related potentials; BIS; Bispectral Index; Response Entropy; State Entropy

Outcome Measures

Primary Outcomes (1)

• 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

  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)

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

Secondary Outcomes (1)

• BIS-Index Awake and 3 Sedation Levels (RS 2/3/4)

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

Study Arms (2)

Dex/Remi followed by Mida/Remi

ACTIVE COMPARATOR

Sedation with dexmedetomidine and remifentanil followed by sedation with midazolam and remifentanil separated by one week

Drug: Dexmedetomidine; Drug: Midazolam; Drug: Remifentanil

Mida/Remi followed by Dexa/Remi

ACTIVE COMPARATOR

Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week

Drug: Dexmedetomidine; Drug: Midazolam; Drug: Remifentanil

Interventions

Dexmedetomidine DRUG

Infusion of dexmedetomidine

Dex/Remi followed by Mida/Remi; Mida/Remi followed by Dexa/Remi

Midazolam DRUG

Midazolam infusion

Dex/Remi followed by Mida/Remi; Mida/Remi followed by Dexa/Remi

Remifentanil DRUG

Infusion of remifentanil

Dex/Remi followed by Mida/Remi; Mida/Remi followed by Dexa/Remi

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18 years and older
• healthy

You may not qualify if:

• History of problems during anesthesia
• Impairment of the auditory system

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• GE Healthcare: collaborator

Study Sites (1)

Departement of Intensive Care Medicine - University Hospital Bern - Inselspital

Bern, 3010, Switzerland

Location

Related Publications (3)

• Haenggi M, Ypparila H, Takala J, Korhonen I, Luginbuhl M, Petersen-Felix S, Jakob SM. Measuring depth of sedation with auditory evoked potentials during controlled infusion of propofol and remifentanil in healthy volunteers. Anesth Analg. 2004 Dec;99(6):1728-1736. doi: 10.1213/01.ANE.0000135634.46493.0A.

  PMID: 15562062 BACKGROUND

• Haenggi M, Ypparila H, Hauser K, Caviezel C, Korhonen I, Takala J, Jakob SM. The effects of dexmedetomidine/remifentanil and midazolam/remifentanil on auditory-evoked potentials and electroencephalogram at light-to-moderate sedation levels in healthy subjects. Anesth Analg. 2006 Nov;103(5):1163-9. doi: 10.1213/01.ane.0000237394.21087.85.

  PMID: 17056949 RESULT

• Haenggi M, Ypparila-Wolters H, Hauser K, Caviezel C, Takala J, Korhonen I, Jakob SM. Intra- and inter-individual variation of BIS-index and Entropy during controlled sedation with midazolam/remifentanil and dexmedetomidine/remifentanil in healthy volunteers: an interventional study. Crit Care. 2009;13(1):R20. doi: 10.1186/cc7723. Epub 2009 Feb 19.

  PMID: 19228415 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Midazolam; Remifentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Results Point of Contact

• Title: Dr. M. Hänggi
• Organization: University Hospital Bern, Switzerland

matthias.haenggi@insel.ch

0316323029

Study Officials

• Matthias Haenggi, MD

  University of Bern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 25, 2008
• First Posted: March 24, 2008
• Study Start: March 1, 2004
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: November 22, 2011
• Results First Posted: November 22, 2011

Record last verified: 2011-10

Locations

CH (1)