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

Centre Hospitalier Universitaire de Besancon

Status and phase: Completed; Phase 3

Conditions: Tumor of Ear, Nose and Throat

Treatments: Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02093143

P/2008/78

Details and patient eligibility

About

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.

Enrollment: 256 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective diagnostic panendoscopy of the upper airway
• Age > 18 and < 80 years old
• American Society of Anesthesiology (ASA) score equal to 1, 2, or 3 with a stable condition
• Written inform consent

Exclusion criteria

• Pregnancy or breastfeeding
• Age < 18 years old or inability to give informed consent
• Known anaphylaxis to remifentanil or propofol
• Long term opioid use, drug abuse
• Predictive criterion of impossible mask ventilation or intubation
• Chronic respiratory failure requiring oxygen therapy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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256 participants in 2 patient groups, including a placebo group

Remifentanil

Experimental group

Description:

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.

Treatment:

Drug: Remifentanil

Placebo

Placebo Comparator group

Description:

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.