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Comparison of Adequacy of Anesthesia Monitoring With Standard Clinical Practice During Routine General Anesthesia

NCT01928875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 496

Last updated 2017-05-01

No results posted yet for this study

Summary

The purpose of this study is to demonstrate that using Surgical Pleth Index (SPI) and Entropy in adjunct to other clinical information decreases the occurrence rate of inadequate anesthesia events, bradycardia and hypotension in comparison to standard clinical practice during anesthesia. Adequacy of Anesthesia (AoA) monitoring comprises the use of both Entropy and SPI measurements. Adequacy of anesthesia will be monitored using non-invasive blood pressure, blood oxygen saturation (SpO2), ECG, and neuromuscular transmission (NMT).

Conditions

  • Surgical Procedure, Unspecified

Interventions

DEVICE

AoA Monitoring

Monitoring with Entropy and SPI parameters during surgery

DEVICE

Routine (Standard) Anesthesia Monitoring

Standard of care monitoring

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-02-01

Countries

  • Finland
  • Germany
  • Hungary
  • Netherlands

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 NCT01928875 on ClinicalTrials.gov