Study Stopped
Poor enrollment.
Use of Bispectral Index (BIS) for Monitoring of Total Intravenous Anaesthesia in Pediatric Patients
1 other identifier
interventional
157
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 4, 2010
CompletedFirst Posted
Study publicly available on registry
January 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJune 25, 2015
June 1, 2015
2.2 years
January 4, 2010
June 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to extubation since the interruption in the administration of anaesthetics.
30 minutes-3 hours
Secondary Outcomes (3)
Consumption of Remifentanil at induction and during maintenance of general anesthesia.
30 minutes-3 hours
Average BIS during the surgical procedure
30min-3hours
Consumption of Propofol during the induction and maintenance of anesthesia.
30 minutes-3 hours
Study Arms (2)
Control
ACTIVE COMPARATORPatients 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.
Bispectral Index Monitor
EXPERIMENTALPatients 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.
Interventions
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 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 (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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Psychiatric disorder
- Use of psychotherapeutic, antiepileptic, antiarrhythmic drugs
- Chronic use of opioids
- Intake of more than 21 alcoholic drinks/week
- Missing informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aalborg Hospital, 4th. dept of Anaesthesiology, Division for Ear Nose and Troath anaesthesia
Aalborg, Nord Jylland, 9800, Denmark
Related Publications (1)
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.
PMID: 23855759DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 4, 2010
First Posted
January 7, 2010
Study Start
January 1, 2010
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
June 25, 2015
Record last verified: 2015-06