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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.
The participants to the study are patients undergoing the following operations: Tonsillectomy, Adenoidectomy, Microlaryngoscopy, Bronchoscopy, Esophagoscopy, Myringoplastic, 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
Propofol, Remifentanil, Bispectral Index Monitor
Aalborg Hospital, 4th. dept of Anaesthesiology, Division for Ear Nose and Troath anaesthesia
Published on BioPortfolio: 2014-07-23T21:11:12-0400
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Abnormally slow pace of regaining CONSCIOUSNESS after general anesthesia (ANESTHESIA, GENERAL) usually given during surgical procedures. This condition is characterized by persistent somnolence.
An intravenous anesthetic agent which has the advantage of a very rapid onset after infusion or bolus injection plus a very short recovery period of a couple of minutes. (From Smith and Reynard, Textbook of Pharmacology, 1992, 1st ed, p206). Propofol has been used as ANTICONVULSANTS and ANTIEMETICS.
Rare and often fatal drug complication which affects patients undergoing long-term treatment with high doses of PROPOFOL. It is characterized by METABOLIC ACIDOSIS; HYPERLIPIDEMIA; RHABDOMYOLYSIS; cardiovascular CIRCULATORY COLLAPSE; CARDIAC FAILURE; and KIDNEY FAILURE.
The period of emergence from general anesthesia, where different elements of consciousness return at different rates.
A barbiturate that is administered intravenously for the production of complete anesthesia of short duration, for the induction of general anesthesia, or for inducing a hypnotic state. (From Martindale, The Extra Pharmacopoeia, 30th ed, p919)
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