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The Use of Surgical Pleth Index in Guiding Anesthesia in Gastroenterological Surgery

NCT04519203 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-11-25

No results posted yet for this study

Summary

Surgical Pleth Index (SPI) is an intraoperative monitor aimed into detection of nociception and guidance of intraoperative opioid administration. Using such a device opioid administration could be potentially optimized during intraoperative period. this study will aim to show whether SPI could be used to reduce unwanted events and lower opioid consumption in gastroenterological surgery. The study will be blinded and randomized including two study arms with either SPI monitoring included or standard monitoring alone.

Conditions

  • Intraoperative Complications
  • Intraoperative Hypotension
  • Intraoperative Hypertension

Interventions

DEVICE

SPI

Either standard monitoring alone or added with SPI

DEVICE

Standard

Standard monitoring alone

Sponsors & Collaborators

  • general electric healthcare Finland

    collaborator UNKNOWN

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Jarkko Harju, MD, PhD · Tampere University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2021-11-01
Completion
2021-11-01

Countries

  • Finland

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 NCT04519203 on ClinicalTrials.gov