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NCT Number: NCT02093143

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

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.

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Key information

Conditions

Tumor of Ear, Nose and Throat Ear Diseases Ear Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHRU Besançon, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

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.

Other names: Ultiva

Primary outcomes

  1. Proportion of patients presenting clinically acceptable conditions for the diagnostic panendoscopy of the upper airway

    Time frame: During 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.

Secondary outcomes

  1. DeltaHRmax

    Time frame: During the diagnostic panendoscopy

    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.

  2. DeltaHRmin

    Time frame: During the diagnostic panendoscopy

    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.

  3. DeltaMAPmin

    Time frame: During the diagnostic panendoscopy

    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.

  4. DeltaMAPmax

    Time frame: During the diagnostic pandoscopy

    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).

  5. Proportion of patients presenting at least one episode of moderate hypoxemia

    Time frame: During the diagnostic panendoscopy

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

  6. Proportion of patients presenting at least one episode of severe hypoxemia

    Time frame: During the diagnostic panendoscopy

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

  7. Proportion of patients requiring invasive mechanical ventilation

    Time frame: During the diagnostic panendoscopy

    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.

  8. Proportion of patients presenting surgery complications

    Time frame: During the 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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.

Acronym: ENDOTANIL

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 20, 2014
Registry last updated
Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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