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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Tumor of Ear, Nose and Throat

Intervention / Treatment
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* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remifentanil<br>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. | Drug: Remifentanil<br>* 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.<br>* Other names: Ultiva;|
| Placebo Comparator: Placebo<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients presenting clinically acceptable conditions for the diagnostic panendoscopy of the upper airway | 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. | During the diagnostic panendoscopy of the upper airway | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DeltaHRmax | 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. | During the diagnostic panendoscopy | 
| DeltaHRmin | 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. | During the diagnostic panendoscopy | 
| DeltaMAPmin | 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. | During the diagnostic panendoscopy | 
| DeltaMAPmax | 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). | During the diagnostic pandoscopy | 
| Proportion of patients presenting at least one episode of moderate hypoxemia | Moderate hypoxemia is defined as a pulse oximetry value (SpO2) under 94% during the diagnostic panendoscopy of the upper airway. | During the diagnostic panendoscopy | 
| Proportion of patients presenting at least one episode of severe hypoxemia | Severe hypoxemia is defined as a pulse oximetry value (SpO2) under 90% during the diagnostic panendoscopy of the upper airway. | During the diagnostic panendoscopy | 
| Proportion of patients requiring invasive mechanical ventilation | 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. | During the diagnostic panendoscopy | 
| Proportion of patients presenting surgery complications | 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. | During the panendoscopy of the upper airway | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic panendoscopy of the upper airway, Total intravenous general anesthesia, Remifentanil, Propofol, Target controlled infusion, Direct laryngoscopy, Tracheoscopy, Oesophagoscopy, Ear Nose and Throat (ENT) tumor, Ear Nose and Throat (ENT) cancer