Clinical trial NCT02093143: Conditions of Diagnostic Panendoscopy of the Upper Airway Under Propofol Remifentanil General Anesthesia
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tumor of Ear, Nose and Throat
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
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients presenting clinically acceptable conditions for the diagnostic panendoscopy of the upper airway
timeFrame: During the diagnostic panendoscopy of the upper airway
Secondary outcomes:
measure: DeltaHRmax
timeFrame: During the diagnostic panendoscopy
measure: DeltaHRmin
timeFrame: During the diagnostic panendoscopy
measure: DeltaMAPmin
timeFrame: During the diagnostic panendoscopy
measure: DeltaMAPmax
timeFrame: During the diagnostic pandoscopy
measure: Proportion of patients presenting at least one episode of moderate hypoxemia
timeFrame: During the diagnostic panendoscopy
measure: Proportion of patients presenting at least one episode of severe hypoxemia
timeFrame: During the diagnostic panendoscopy
measure: Proportion of patients requiring invasive mechanical ventilation
timeFrame: During the diagnostic panendoscopy
measure: Proportion of patients presenting surgery complications
timeFrame: During the panendoscopy of the upper airway
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire
city: Besançon
country: France
facility: CHRU Besançon
Study officials:
affiliation: CHRU Besançon
name: Sébastien Pili Floury, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Besançon
name: Angéline Chopard-Guillemin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Besançon
name: Amélie Jurine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Besançon
name: Guillaume Besch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Besançon
name: Arnaud Causeret, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schnider TW, Minto CF, Gambus PL, Andresen C, Goodale DB, Shafer SL, Youngs EJ. The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers. Anesthesiology. 1998 May;88(5):1170-82. doi: 10.1097/00000542-199805000-00006.
citation: Minto CF, Schnider TW, Egan TD, Youngs E, Lemmens HJ, Gambus PL, Billard V, Hoke JF, Moore KH, Hermann DJ, Muir KT, Mandema JW, Shafer SL. Influence of age and gender on the pharmacokinetics and pharmacodynamics of remifentanil. I. Model development. Anesthesiology. 1997 Jan;86(1):10-23. doi: 10.1097/00000542-199701000-00004.
citation: Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33. doi: 10.1097/00000542-199701000-00005.