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Use of Bispectral Index (BIS) for Monitoring of Total Intravenous Anaesthesia in Pediatric Patients

NCT01043952 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2015-06-25

No results posted yet for this study

Summary

The objective of the study is to determine wether the use of the Bispectral Index Monitor (BIS) as a method to guide anaesthesia for children in different groups of age, undergoing ear nose and throat surgery anaesthetized with an infusion of Propofol and Remifentanil with an high dose of Remifentanil (0,5-2 mcg/kg/min), can lead to a reduction in the time needed for extubation and in the amount of anesthetics used.

Conditions

  • Anesthesia, General

Interventions

DRUG

Propofol

Propofol is used as an anesthetic drug on all patients, with the dosing depending on patient age, weight, body mass index, general status, the hemodynamic and neurophysiological response to the previously administered dose and the degree of surgical stimulation, and in the Bispectral Index Monitor arm, depending on the BIS values.

DRUG

Remifentanil

Remifentanil is used as analgesic drug, as a part of the total intravenous anaesthesia, on all patients, with the dosing depending on patient age, weight, body mass index, general status, the hemodynamic and neurophysiological response to the previously administered dose and the degree of surgical stimulation, and in the Bispectral Index Monitor arm, depending on the BIS values.

DEVICE

Bispectral Index Monitor

Bispectral Index Monitor (BIS monitor integrated in the IntelliVue Patient monitor MP70, Philips) is used to monitor the depth of anesthesia. The values this monitor reports are used as an aid in evaluating the response of the single patient to the administered anesthetics, and as a guide in adjusting the dosing of anesthetics. We follow the algorithm from: http://www.biseducation.com/assets.aspx?ac=1 (ASA Practice Advisory White Paper)

Sponsors & Collaborators

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Piergiorgio Bresil, MD · Aalborg Hospital, 4th dept. of Anaesthesiology Region Nordjylland

  • Per H Lambert, MD · Aalborg Hospital, 4th. dept. of Anaesthesiology Region Nordjylland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Denmark

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 NCT01043952 on ClinicalTrials.gov