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

This study has been terminated.
(The study is terminated due to poor enrollment with subsequent low number of participants. No safety or efficacy issues were involved.)
Sponsor:
Information provided by (Responsible Party):
Piergiorgio Bresil, Aalborg Hospital
ClinicalTrials.gov Identifier:
NCT01043952
First received: January 4, 2010
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Anesthesia, General
Drug: Propofol
Drug: Remifentanil
Device: Bispectral Index Monitor
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Use of Bispectral Index (BIS) Monitoring of Anaesthesia With Propofol and Remifentanyl in Pediatric Patients in Ear Nose and Throat Surgery: Are There Clinical Advantages?

Resource links provided by NLM:


Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • Consumption of Propofol during the induction and maintenance of anesthesia. [ Time Frame: 30 minutes-3 hours ] [ Designated as safety issue: No ]
  • Time to extubation since the interruption in the administration of anaesthetics. [ Time Frame: 30 minutes-3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Consumption of Remifentanil at induction and during maintenance of general anesthesia. [ Time Frame: 30 minutes-3 hours ] [ Designated as safety issue: No ]
  • Average BIS during the surgical procedure [ Time Frame: 30min-3hours ] [ Designated as safety issue: No ]
    Experimental arm: the anesthetist can read the values on the anaesthesia monitor and use them together with other clinical parameters to adjust the depth of the anaesthesia. Control arm: the BIS values are recorded in an hidden window of the anaesthesia monitor (they are not immediately available to the anesthetist), and are collected only at the end of the anaesthesia from a third person.


Enrollment: 157
Study Start Date: January 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control

Patients receive general anesthesia following clinical practice, without the use of a cerebral state monitor as Bispectral Index Monitor.

Stratification by age (1-3 y, 4-11y, 12-17y, 18-65y) will be performed to ensure balanced allocation of age groups and allow for identification of age and weight specific effects.

Stratification by operation type will be performed to ensure the identification of the effects of the duration of anaesthesia and of the use of longer acting opioids (Fentanyl) on outcome parameters.

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.
Other Name: Ultiva
Experimental: Bispectral Index Monitor

Patients receive a general anesthesia where the amount of anesthetics administered is decided taking into consideration the Bispectral Index monitor.

Stratification by age (1-3 y, 4-11y, 12-17y, 18-65y) will be performed to ensure balanced allocation of age groups and allow for identification of age and weight specific effects.

Stratification by operation type will be performed to ensure the identification of the effects of the duration of anaesthesia and of the use of longer acting opioids (Fentanyl) on outcome parameters.

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.
Other Name: Ultiva
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)

Detailed Description:

The participants to the study are patients undergoing the following operations: Tonsillectomy, Adenoidectomy, Microlaryngoscopy, Bronchoscopy, Esophagoscopy, Myringoplasty, Myringotomy with positioning of a tube.

All these procedures are performed with the patient receiving a general anesthesia with and infusion of Propofol and Remifentanil. Muscle relaxants and inhaled anesthetics are not used.

The patients undergoing a Tonsillectomy will receive a supplementary opioid analgesic (Inj. Fentanyl iv, 3mcg/kg) at the end of the surgical procedure. Patients undergoing the other operations receive intraoperative Paracetamol and NSAID for postoperative pain treatment.

Stratification by age (1-3y, 4-11y, 12-17y, 18-65y) will be performed to ensure balanced allocation of age groups and allow for identification of age and weight specific effects. Stratification by operation type will be performed to ensure the identification of the effects of the duration of anaesthesia and of the use of longer acting opioids (Fentanyl) on outcome parameters.

  Eligibility

Ages Eligible for Study:   1 Year to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status 1 or 2
  • General anesthesia for the following operations: Tonsillectomy, Adenoidectomy, Myringoplasty, Myringotomy with tube placement, microlaryngoscopy, bronchoscopy and esophagoscopy.

Exclusion Criteria:

  • Psychiatric disorder
  • Use of psychotherapeutic, antiepileptic, antiarrhythmic drugs
  • Chronic use of opioids
  • Intake of more than 21 alcoholic drinks/week
  • Missing informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043952

Locations
Denmark
Aalborg Hospital, 4th. dept of Anaesthesiology, Division for Ear Nose and Troath anaesthesia
Aalborg, Nord Jylland, Denmark, 9800
Sponsors and Collaborators
Aalborg Universityhospital
Investigators
Principal Investigator: Piergiorgio Bresil, MD Aalborg Hospital, 4th dept. of Anaesthesiology Region Nordjylland
Study Director: Per H Lambert, MD Aalborg Hospital, 4th. dept. of Anaesthesiology Region Nordjylland
  More Information

No publications provided by Aalborg Universityhospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Piergiorgio Bresil, MD, Aalborg Hospital
ClinicalTrials.gov Identifier: NCT01043952     History of Changes
Other Study ID Numbers: N-20090035
Study First Received: January 4, 2010
Last Updated: April 9, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Aalborg Universityhospital:
Propofol
Remifentanil
Bispectral Index Monitor

Additional relevant MeSH terms:
Anesthetics
Propofol
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2014