Neoplasms

Ear, Nose, and Throat Diseases

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Ear Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Ear Diseases

Otorhinolaryngologic Diseases

Central Nervous System Depressants

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Anesthetics

Propofol

Remifentanil

Analgesics, Opioid

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The general anesthesia during the diagnostic panendoscopy of the upper airway will associate the target controlled infusion of propofol (pharmacologic model of Schnider et al.) and of remifentanil (pharmacologic model of Minto et al.) in the remifentanil group.

The arm will be randomized prior to the beginning of the surgical procedure and blinded to the investigator and to the practitioner in charge of the patient.

Two milligrams of remifentanil will be diluted in 40 cc of sodium chloride 0,9% in a 50 ml syringe.

The general anesthesia during the diagnostic panendoscopy of the upper airway will consist in the target controlled infusion of propofol alone (pharmacologic model of Schnider et al.) in the placebo group.

The placebo is a 40 ml sodium chloride 0,9% solution in a 50 ml syringe. No one can distinguish the syringe of placebo from the syringe of remifentanil.

Target-controlled infusion of remifentanil 50 µg/ml using the pharmacologic model of Minto et al. to achieve a theorical brain concentration of 1.5 ng/ml.

Sébastien Pili Floury, MD, PhD

Angéline Chopard-Guillemin, MD

Amélie Jurine, MD

Guillaume Besch, MD

Arnaud Causeret, MD

The most important considerations for the general anesthesia in diagnostic panendoscopy of the upper airway is the maintenance of a patient's airway for optimal surgical exposure, adequate ventilation and sufficient depth of anesthesia. Tubeless anesthestic techniques with preserved spontaneous ventilation and total intravenous administration of anesthetic drugs are widely use. Due to its pharmacological profile, propofol anesthesia is often considered as the gold standard for the anesthesia in the diagnostic panendoscopy. Previous studies suggested that adding remifentanil to propofol could improve the conditions for laryngoscopy and tracheal intubation.

The aim of this study is to assess the impact of propofol remifentanil general anesthesia compared to propofol general anesthesia on the conditions of the diagnostic panendoscopy of the upper airway.

Conditions of Diagnostic Panendoscopy of the Upper Airway Under Propofol Remifentanil General Anesthesia

Evaluation of the Impact of Adding Remifentanil to Propofol on the Conditions of the Diagnostic Panendoscopy of the Upper Airway Under General Anesthesia With Tubeless Spontaneous Ventilation.

The assessment of the conditions for the diagnotic panendoscopy of the upper airway will be based on: (1) the conditions for the laryngoscopy ("excellent"=easy; "good"=fair; "poor"=difficult), (2) the position of the vocal cords ("excellent"=abducted; "good"=intermediate; "poor"=closed), (3) the movements of the vocal cords ("excellent"=none; "good"=moving; "poor"=closing), (4) the movement of the limbs ("excellent"=none; "good"=sight; "poor"=vigorous), (5) the cough ("excellent"=none; "good"=diaphragm; "poor"=sustained (\>10 s)). The conditions for the diagnostic panendoscopy will be considered as "excellent" when all variables will be excellent, as "good" when all variables will be either good or excellent and as "poor" when one or more variables will be graded as poor. Clinically acceptable conditions are defined as either good or excellent conditions.

The DeltaHRmax characterises the amplitude of the maximal increase of the heart rate during the diagnostic panendoscopy of the upper airway. The DeltaHRmax is defined as following: deltaHRmax=((HRmax-HRt0)\*100)/HRt0). HRmax is the highest value of the heart rate observed during the panendoscopy and HRt0 is the basal value of the heart rate.

The DeltaHRmin characterises the amplitude of the maximal decrease of the heart rate during the diagnostic panendoscopy of the upper airway. The DeltaHRmin is defined as following: deltaHRmin=((HRt0-HRmin)\*100)/HRt0). HRmin is the lowest value of the heart rate observed during the panendoscopy and HRt0 is the basal value of the heart rate.

The DeltaMAPmin characterises the amplitude of the maximal decrease of the heart rate during the diagnostic panendoscopy of the upper airway. The DeltaHRmin is defined as following: deltaHRmin=((HRt0-HRmin)\*100)/HRt0). HRmin is the lowest value of the heart rate observed during the panendoscopy and HRt0 is the basal value of the heart rate.

The DeltaMAPmax characterises the amplitude of the maximal increase of the mean arterial pressure (MAP) during the diagnostic panendoscopy of the upper airway. The DeltaMAPmax is defined as following: deltaMAPmax=((MAPmax-MAPt0)\*100)/MAPt0). MAPmax is the highest value of the mean arterial pressure (MAP) observed during the panendoscopy and MAPt0 is the basal value of the mean arterial pressure (MAP).

Moderate hypoxemia is defined as a pulse oximetry value (SpO2) under 94% during the diagnostic panendoscopy of the upper airway.

Severe hypoxemia is defined as a pulse oximetry value (SpO2) under 90% during the diagnostic panendoscopy of the upper airway.

Invasive mechanical ventilation via an emergent surgical tracheotomy or an endotracheal intubation could be required in case of life-threatened hypoxemia during the diagnostic panendoscopy of the upper airway.

Surgical complications are defined as dental breakage, bleeding or mucosal injuries directly related to the diagnostic panendoscopy of the upper airway or to the biopsy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Conditions of Diagnostic Panendoscopy of the Upper Airway Under Propofol Remifentanil General Anesthesia	NCT02093143	Tumor of Ear, N...	Remifentanil	18 Years - 80 Years	Centre Hospitalier Universitaire de Besancon
Conditions of Diagnostic Panendoscopy of the Upper Airway Under Propofol Remifentanil General Anesthesia	NCT02093143	Tumor of Ear, N...	Remifentanil	18 Years - 80 Years	Centre Hospitalier Universitaire de Besancon

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