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Guiding Opioid Administration in Patients With Regional Anesthesia

NCT06040307 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-05-13

No results posted yet for this study

Summary

General anesthesia is a combination of hypnotic drugs to achieve unconsciousness and opioid analgesics to ensure antinociception. An alternative approach to the intraoperative administration of high potency opioids in order to achieve antinociception during surgery is combining a general anesthesia with a regional anesthesia.

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. Recently different monitoring devices estimating the effect of nociception during unconsciousness have become commercially available. One of the first commercially available nociception indices was the Surgical Pleth Index (SPI) derived by the CARESCAPE™B650 patient monitor (GE Healthcare).

Until today, it remains unknown whether guiding sufentanil administration by SPI monitoring affects the administered amount of intraoperative and postoperative opioid, immediate postoperative pain in the postanesthesia care unit (PACU) and the quality of postoperative recovery in patients with a combination of general and regional anesthesia. This study aims to investigate whether guiding sufentanil administration by SPI monitoring - compared to routine care - reduces intraoperative sufentanil consumption in patients having trauma and orthopaedic surgery with a combination of general and regional anesthesia.

Conditions

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

Interventions

PROCEDURE

SPI (Surgical Pleth Index)

Elective surgery in patients having trauma and orthopedic surgery with a combination of general and regional anesthesia. Opioid titration is guided by SPI during general anesthesia in the experimental arm.

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Rainer Nitzschke, MD · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2024-04-09
Completion
2024-05-06

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 NCT06040307 on ClinicalTrials.gov