Anesthesia, General Clinical Trial
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?
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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