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Monitor-Guided Analgesia During General Anesthesia - Part I

NCT03303651 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-04-25

No results posted yet for this study

Summary

This prospective randomized clinical trial evaluates the effects of a monitor-guided opioid analgesia during general anesthesia. To date no standard-monitoring device exists to specifically reflect the analgesic component of general anesthesia. Quality and safety of general anesthesia are of major clinical importance and should be improved by limiting the opioid analgesic's dosage to the minimum amount needed. The study compares the effects of monitoring nociception during general anesthesia with different innovative techniques in comparison to routine clinical practice.

Conditions

  • Pain
  • Pain, Postoperative
  • Nociceptive Pain
  • Opioid Use
  • Analgesia

Interventions

PROCEDURE

Opioid administration in intervention groups

Elective surgery in radical open abdominal prostatectomy. Opioid titration is guided by analgesia indices during general anesthesia in the experimental arms.

PROCEDURE

Opioid administration in control group

Elective surgery in radical open abdominal prostatectomy. Opioid titration is guided by clinical signs in the control group.

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Rainer Nitzschke, MD · Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center

  • Sandra Funcke, MD · Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2017-12-05
Completion
2018-01-26

Countries

  • Germany

Study Locations

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Entities

Diseases

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 NCT03303651 on ClinicalTrials.gov