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

NCT ID: NCT01043952

Last Updated: 2015-06-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-03-31

Brief 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.

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.

Conditions

Anesthesia, General

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Patients receive general anesthesia with Propofol and Remifentanil following clinical practice.

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.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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.

Remifentanil

Intervention Type: DRUG

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.

Bispectral Index Monitor

Patients receive a general anesthesia with Propofol and Remifentanil 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.

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

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.

Remifentanil

Intervention Type: DRUG

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.

Bispectral Index Monitor

Intervention Type: DEVICE

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)

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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)

Intervention Type: DEVICE

Other Intervention Names

Ultiva

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Piergiorgio Bresil

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Piergiorgio Bresil, MD

Role: PRINCIPAL_INVESTIGATOR

Aalborg Hospital, 4th dept. of Anaesthesiology Region Nordjylland

Per H Lambert, MD

Role: STUDY_DIRECTOR

Aalborg Hospital, 4th. dept. of Anaesthesiology Region Nordjylland

Locations

Aalborg Hospital, 4th. dept of Anaesthesiology, Division for Ear Nose and Troath anaesthesia

Aalborg, Nord Jylland, Denmark

Countries

Denmark

References

Bresil P, Nielsson MS, Malver LP, Kraemer K, Schjorring O, Dethlefsen C, Lambert PH. Impact of bispectral index for monitoring propofol remifentanil anaesthesia. A randomised clinical trial. Acta Anaesthesiol Scand. 2013 Sep;57(8):978-87. doi: 10.1111/aas.12158. Epub 2013 Jul 15.

Reference Type: DERIVED

PMID: 23855759 (View on PubMed)

Other Identifiers

N-20090035

Identifier Type: -

Identifier Source: org_study_id