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?
Overview
- Phase
- Not Applicable
- Intervention
- Propofol
- Conditions
- Anesthesia, General
- Sponsor
- Aalborg University Hospital
- Enrollment
- 157
- Locations
- 1
- Primary Endpoint
- Time to extubation since the interruption in the administration of anaesthetics.
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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.
Investigators
Piergiorgio Bresil
MD
Aalborg University Hospital
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
Arms & Interventions
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.
Intervention: Propofol
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.
Intervention: Remifentanil
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.
Intervention: Propofol
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.
Intervention: Remifentanil
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.
Intervention: Bispectral Index Monitor
Outcomes
Primary Outcomes
Time to extubation since the interruption in the administration of anaesthetics.
Time Frame: 30 minutes-3 hours
Secondary Outcomes
- 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)