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

Information source: Aalborg Universitetshospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anesthesia, General

Intervention: Propofol (Drug); Remifentanil (Drug); Bispectral Index Monitor (Device)

Phase: N/A

Status: Terminated

Sponsored by: Aalborg Universitetshospital

Official(s) and/or principal investigator(s):
Piergiorgio Bresil, MD, Principal Investigator, Affiliation: Aalborg Hospital, 4th dept. of Anaesthesiology Region Nordjylland
Per H Lambert, MD, Study Director, Affiliation: Aalborg Hospital, 4th. dept. of Anaesthesiology Region Nordjylland


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.

Clinical Details

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?

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Time to extubation since the interruption in the administration of anaesthetics.

Secondary outcome:

Consumption of Remifentanil at induction and during maintenance of general anesthesia.

Average BIS during the surgical procedure

Consumption of Propofol during the induction and maintenance of anesthesia.

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.


Minimum age: 1 Year. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

Aalborg Hospital, 4th. dept of Anaesthesiology, Division for Ear Nose and Troath anaesthesia, Aalborg, Nord Jylland 9800, Denmark
Additional Information

Starting date: January 2010
Last updated: June 23, 2015

Page last updated: August 23, 2015

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