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Prediction of Postoperative Pain by Nociception Monitoring

NCT05063227 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-07-05

No results posted yet for this study

Summary

General anesthesia is a combination of hypnotic drugs and opioid analgesics. Modern general anesthesia aims to treat nociception induced by surgical stimulation while avoiding an overdose of opioid analgesics and reducing side-effects of opioid administration. Quality and safety of general anesthesia are of major clinical importance and can be improved by adjusting the opioid analgesics to the optimal individual dose needed. In the current clinical practice, the opioid dosage is usually chosen by clinical judgment, though recently different monitoring devices estimating the effect of nociception during unconsciousness have become commercially available. Nevertheless, the impact of nociception-monitor-guided opioid administration on the administered amount of opioid, postoperative short-term recovery, and long-term outcome is inconclusive. This study aims to investigate the predictive power of different nociception monitoring systems for the prediction of moderate to severe immediate postoperative pain from nociception indices measured before awakening from general anesthesia.

Conditions

  • Pain, Postoperative
  • Analgesia
  • Anesthesia Recovery Period
  • Opioid Use

Interventions

DIAGNOSTIC_TEST

Observational: analgesia monitoring indices and changes in heart rate

After the end of surgery (defined as the time of skin closure or wound dressing), but before awakening (BIS will still be \< 60), SPI, PPI and NOL are recorded in a quiet setting without any other stimulation. Within the five minutes data acquisition period nociception indices are recorded every minute (T0, T1, T2, T3, T4, T5). The highest SPI, PPI and NOL are used for further analysis.

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Rainer Nitzschke, MD · Center for Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2021-12-02
Completion
2023-01-04

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 NCT05063227 on ClinicalTrials.gov