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Correlation of subjective pain perception (VAS) and contact heat evoked potentials (CHEP) under remifentanil induced analgesia - with concomitant rating of vigilance by auditory evoked potentials (AEP) and OAA/S-score and analysis of synergistic drug effects on CHEP during propofol-induced loss of consciousness

Correlation of subjective pain perception (VAS) and contact heat evoked potentials (CHEP) under remifentanil induced analgesia - with concomitant rating of vigilance by auditory evoked potentials (AEP) and OAA/S-score and analysis of synergistic drug effects on CHEP during propofol-induced loss of consciousness

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00003300
Enrollment
120
Registered
2011-10-24
Start date
2013-01-31
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pain during anesthesia R52.9

Interventions

Group 1: measurements without drug application about 30 minutes
after that measurements under 0,05 µg/kg/min remifentanil-infusion (i.v., continuously) about 40 minutes
in the course of the trail additional propofol-infusion until loss of consciousness (defined when volunteers stop squeezing the investigator's hand although requested)
occurs shortly after propofol-induction and persists by continuous i.v. propofol-infusion
duration of combined remifentail/propofol-infusion about 30 minutes Group 2: measurements without drug application about 30 minutes
after that measurements under 0,10 µg/kg/min remifentanil-infusion (i.v., continuously) about 40 minutes
duration of combined remifentail/propofol-infusion about 30 minutes Group 3: measurements without drug application about 30 minutes
after that measurements under 0,20 µg/kg/min remifentanil-infusion (i.v., continuously) about 40 minutes
duration of combined remifentail/propofol-infusion about 30 minutes Group 4: measurements without drug application about 30 minutes
after that measurements under 0,40 µg/kg/min remifentanil-infusion (i.v., continuously) about 40 minutes
in the course of the trail additional propofol-infusion until loss of consciousness (defined when volunteers stop squeezing the i

Sponsors

Zentrum für Anästhesiologie, Helios Klinikum Wuppertal, Universität Witten/Herdecke
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: ASA physical status 1-2 (classification system to assess fitness of patients before surgery): correlates with healthy patients (ASA 1) and patients with mild systemic disease (ASA 2), written consent, mental capacity, age: 18-50 years

Exclusion criteria

Exclusion criteria: cardiac, hepatic, renal, pulmonary or gastrointestinal diseases, disorders of gastrointestinal motility, psychiatric and neurologic diseases, altered cerebral perfusion, chronic intake of drugs, psychotropics or other substances with central- or peripheral nervous effects, hypacusis and deafness, analgetic long-term medication, chronic pain, agitated or anxious patients, allergy, known intolerance and contraindications against the used drugs, pregnancy

Design outcomes

Primary

MeasureTime frame
correlation between individual pain perception (described by visual analogue scale, VAS) and CHEP-amplitudes (Contact Heat Evoked Potentials) as the electroencephalographic correlate of the applied heat pain under remifentanil als analgesic. Remifentanil-induced changes of VAS and CHEP will be compared to the baseline measurement without drug application and will be analyzed under four different remifentanil-concentrations.

Secondary

MeasureTime frame
- correlation between remifentanil concentration and reduction of CHEP (Contact Heat Evoked Potential)-amplitudes - registration of potential sedative effects of remifentanil by AEP (auditory evoked potentials) and OAA/S-score (Observer's Assessment of Alertness/Sedation-score) - effects of loss of consciousness on CHEP (Contact Heat Evoked Potential) - gender-related differences on CHEP (Contact Heat Evoked Potential)

Countries

Germany

Contacts

Public ContactGisela Untergehrer

Zentrum für Anästhesiologie, Helios Klinikum Wuppertal, Universität Witten/Herdecke

gisela.untergehrer@uni-wh.de+49 202 896 1647

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Sep 18, 2026