Clinical trial NCT01043952: Use of Bispectral Index (BIS) for Monitoring of Total Intravenous Anaesthesia in Pediatric Patients
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia, General
Keywords: Propofol
Remifentanil
Bispectral Index Monitor
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 157
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to extubation since the interruption in the administration of anaesthetics.
timeFrame: 30 minutes-3 hours
Secondary outcomes:
measure: Consumption of Remifentanil at induction and during maintenance of general anesthesia.
timeFrame: 30 minutes-3 hours
measure: Average BIS during the surgical procedure
timeFrame: 30min-3hours
measure: Consumption of Propofol during the induction and maintenance of anesthesia.
timeFrame: 30 minutes-3 hours
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Hospital, 4th. dept of Anaesthesiology, Division for Ear Nose and Troath anaesthesia
state: Nord Jylland
Study officials:
affiliation: Aalborg Hospital, 4th dept. of Anaesthesiology Region Nordjylland
name: Piergiorgio Bresil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg Hospital, 4th. dept. of Anaesthesiology Region Nordjylland
name: Per H Lambert, MD
role: STUDY_DIRECTOR
References:
citation: 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.