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Comparison of Different Analgesia-Monitors in Tracing Unconscious Pain Sensations

NCT02429960 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-09-26

No results posted yet for this study

Summary

Until today there is no standard-monitoring to specifically reflect the analgesic component of general anesthesia. Quality and safety of general anesthesia are of major clinical importance and can be improved by limiting the administration of opioid analgesics to the minimum dose needed. This study therefore examines the quality of three different monitoring techniques (PhysioDoloris, MetroDoloris, Lille, France, SPI (Surgical Plethysmographic Index), GE Healthcare, Helsinki, Finland and AlgiScan, IDMed, Marseille, France) in assessing the level of analgesia during general anesthesia. Therefore a standardized painful stimulus is applied under different levels of analgesic drugs. The monitor's indices are compared to clinical signs such as an increase in heart rate and blood pressure.

Conditions

  • Anesthesia

Interventions

DEVICE

Analgesia monitor (PhysioDoloris®)

Comparison of three different analgesia monitoring systems (PhysioDoloris®, SPI® and AlgiScan®).

DEVICE

Analgesia monitor (SPI®)

Comparison of three different analgesia monitoring systems (PhysioDoloris®, SPI® and AlgiScan®).

DEVICE

Analgesia monitor (AlgiScan®)

Comparison of three different analgesia monitoring systems (PhysioDoloris®, SPI® and AlgiScan®).

DRUG

Remifentanil

Remifentanil will be increased step-by-step from 0.05 mcg/kg/min to 0.2 mcg/kg/min. After ensuring a steady-state period of remifentanil infusion of at least 5 minutes, the standardized painful stimuli will be applied.

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Christian Zoellner, Professor · Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02429960 on ClinicalTrials.gov