Tumor of Ear, Nose and Throat
Conditions
Keywords
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
Brief summary
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.
Interventions
DRUGRemifentanil
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.
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients presenting clinically acceptable conditions for the diagnostic panendoscopy of the upper airway | 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
| Measure | Time frame | Description |
|---|---|---|
| DeltaHRmin | 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. |
| DeltaMAPmin | 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. |
| DeltaMAPmax | 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). |
| DeltaHRmax | 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. |
| Proportion of patients presenting at least one episode of severe hypoxemia | During the diagnostic panendoscopy | Severe hypoxemia is defined as a pulse oximetry value (SpO2) under 90% during the diagnostic panendoscopy of the upper airway. |
| Proportion of patients requiring invasive mechanical ventilation | 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. |
| Proportion of patients presenting surgery complications | 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. |
| Proportion of patients presenting at least one episode of moderate hypoxemia | During the diagnostic panendoscopy | Moderate hypoxemia is defined as a pulse oximetry value (SpO2) under 94% during the diagnostic panendoscopy of the upper airway. |
Countries
France
Outcome results
None listed