- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01043952
Use of Bispectral Index (BIS) for Monitoring of Total Intravenous Anaesthesia in Pediatric Patients
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nord Jylland
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Aalborg, Nord Jylland, Denmark, 9800
- Aalborg Hospital, 4th. dept of Anaesthesiology, Division for Ear Nose and Troath anaesthesia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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. |
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.
Other Names:
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Experimental: 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. |
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.
Other Names:
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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Time to extubation since the interruption in the administration of anaesthetics.
Time Frame: 30 minutes-3 hours
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30 minutes-3 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Consumption of Remifentanil at induction and during maintenance of general anesthesia.
Time Frame: 30 minutes-3 hours
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30 minutes-3 hours
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Average BIS during the surgical procedure
Time Frame: 30min-3hours
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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.
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30min-3hours
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Consumption of Propofol during the induction and maintenance of anesthesia.
Time Frame: 30 minutes-3 hours
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30 minutes-3 hours
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Collaborators and Investigators
Sponsor
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-20090035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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