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Bispectral Index (BIS) Monitoring in Abdominal Surgery

NCT01470898 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-07-10

No results posted yet for this study

Summary

Bispectral Index Monitoring (BIS) has been proven to be effective in preventing awareness. Optimizing anesthesia level using BIS monitoring, neither to light nor to deep will probably help to shorten recovery time and reduce drug consumption. The aim of the study was to investigate the effect of BIS monitoring on extubation and recovery time, and intraoperative anesthesia consumption.

Conditions

  • Anesthesia

Interventions

DEVICE

bispectral index monitoring

A BIS sensor was applied to patient's forehead before induction of anesthesia and connected to A-2000 BIS monitor (Aspect Medical Systems, Newton, MA, USA). It records the electroencephalogram from 4 electrodes and after processing it with mathematic algorithms it generates a number from 0 to 100. When the BIS value is lower than 40, the patient is in deep anesthesia state, when the value is over 80, the patient is under light sedation.At the induction of anesthesia, and every 15 minutes during operation following parameters were recorded: heart rate (HR), systolic blood pressure (BP), end-tidal CO2 (etCO2) and BIS level. Also, operation time and extubation time were recorded. Finally, all patients were visited on the first postoperative day and interviewed about intraoperative recall.

Sponsors & Collaborators

  • University Hospital Dubrava

    lead OTHER

Principal Investigators

  • Jasminka Persec, MD PhD · Anesthesiology, reanimatology and intensive care medicine Clinic, University Hospital Dubrava, Zagreb, Croatia

  • Zoran Persec, MD PhD · Department of urology, University Hospital Dubrava, Zagreb, Croatia

  • Ino Husedzinovic, Professor · Head of Anesthesiology, reanimatology and intensive care medicine Clinic, University Hospital Dubrava, Zagreb, Croatia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-07-31
Completion
2013-02-28

Countries

  • Croatia

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 NCT01470898 on ClinicalTrials.gov