Comparison of Different Analgesia-Monitors in Tracing Unconscious Pain Sensations

NCT02429960 | Completed

• 1 other identifier: AMUPS-012013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nociception; Analgesia; Intraoperative; Monitoring

Outcome Measures

Primary Outcomes (1)

• Comparison of the Pearson correlation coefficient between the dose of analgesic medication (remifentanil) on the one hand and the changes in heart rate, blood pressure and output of the analgesia monitoring systems on the other hand.

  Observation for approximately 30 minutes after anesthesia induction

Secondary Outcomes (1)

• Differences of sensitivity and specificity of the analgesia monitors in detecting a painful stimulus under different doses of remifentanil.

  Observation for approximately 30 minutes after anesthesia induction

Study Arms (1)

Analgesia monitoring

OTHER

Remifentanil is increased step-by-step according to the study protocol. After ensuring a steady-state period of remifentanil infusion of at least 5 minutes, the standardized painful stimuli consisting of the intracutaneous pain model and tetanic stimulation for the time period of 30 s with 80 milliampere, 50 Hz are applied. All stimulations are accompanied by the measurement of the analgesic monitoring-devices (PhysioDoloris®, SPI® and AlgiScan®). Moreover the investigators measure and inspect changes in heart rate and blood pressure as well as occurrence of defensive movements of the patients.

Device: Analgesia monitor (PhysioDoloris®); Device: Analgesia monitor (SPI®); Device: Analgesia monitor (AlgiScan®); Drug: Remifentanil

Interventions

Analgesia monitor (PhysioDoloris®) DEVICE

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

Analgesia monitoring

Analgesia monitor (SPI®) DEVICE

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

Analgesia monitoring

Analgesia monitor (AlgiScan®) DEVICE

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

Analgesia monitoring

Remifentanil DRUG

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.

Analgesia monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists Status I and II
• \> 18 years
• Elective surgery in Urology/Ear Nose Throat under general anesthesia without the use of muscle relaxants

You may not qualify if:

• Diseases with impairment of sensitivity (diabetes, gout, polyneuropathy, peripheral arterial obstructive disease)
• Beta blocker and digitalis therapy
• Chronic pain therapy
• Pacemaker therapy
• Dermal diseases with affection of the forearm/hand

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center

Hamburg, 20246, Germany

Location

Related Links

• Publication of study results - Validation of Innovative Techniques for Monitoring Nociception during General Anesthesia

MeSH Terms

Conditions

Agnosia

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christian Zoellner, Professor

  Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 29, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

DE (1)