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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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?

Conditions
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Anesthesia, General

Intervention / Treatment
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* Drug: Propofol
* Drug: Remifentanil
* Device: Bispectral Index Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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. | Drug: Propofol<br>* 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.<br>Drug: Remifentanil<br>* 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.<br>* Other names: Ultiva;|
| Experimental: Bispectral Index Monitor<br>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. | Drug: Propofol<br>* 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.<br>Drug: Remifentanil<br>* 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.<br>* Other names: Ultiva;Device: Bispectral Index Monitor<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to extubation since the interruption in the administration of anaesthetics. |  | 30 minutes-3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of Remifentanil at induction and during maintenance of general anesthesia. |  | 30 minutes-3 hours | 
| Average BIS during the surgical procedure | 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. | 30min-3hours | 
| Consumption of Propofol during the induction and maintenance of anesthesia. |  | 30 minutes-3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Propofol, Remifentanil, Bispectral Index Monitor