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

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.

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.

Study Overview

• Status: Completed
• Conditions: Tumor of Ear, Nose and Throat
• Intervention / Treatment: Drug: Remifentanil

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • Centre hospitalier régional universitaire
  • Besançon, France, 25000
    • CHRU Besançon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remifentanil; 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; 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
Placebo Comparator: Placebo; 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?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Guillaume Besch, MD, CHRU Besançon; Principal Investigator: Sébastien Pili Floury, MD, PhD, CHRU Besançon; Principal Investigator: Angéline Chopard-Guillemin, MD, CHRU Besançon; Principal Investigator: Amélie Jurine, MD, CHRU Besançon; Principal Investigator: Arnaud Causeret, MD, CHRU Besançon

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: March 19, 2014
• First Posted (Estimate): March 20, 2014

Study Record Updates

• Last Update Posted (Estimate): March 20, 2014
• Last Update Submitted That Met QC Criteria: March 19, 2014
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Remifentanil; Propofol; Target controlled infusion; Direct laryngoscopy; Diagnostic panendoscopy of the upper airway; Total intravenous general anesthesia; Tracheoscopy; Oesophagoscopy; Ear Nose and Throat (ENT) tumor; Ear Nose and Throat (ENT) cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Ear Diseases; Ear Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: P/2008/78