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

NCT02093143 | Completed Phase 3

• 1 other identifier: P/2008/78
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• DeltaHRmax

  During the diagnostic panendoscopy

• DeltaHRmin

  During the diagnostic panendoscopy

• DeltaMAPmin

  During the diagnostic panendoscopy

• DeltaMAPmax

  During the diagnostic pandoscopy

• Proportion of patients presenting at least one episode of moderate hypoxemia

  During the diagnostic panendoscopy

Study Arms (2)

Remifentanil

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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.

Interventions

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.

Also known as: Ultiva

Remifentanil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (2)

CHRU Besançon

Besançon, France, 25000, France

Location

Centre Hospitalier Régional Universitaire

Besançon, 25000, France

Location

Related Publications (3)

• 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.

  PMID: 9605675 BACKGROUND

• 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.

  PMID: 9009935 BACKGROUND

• 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.

  PMID: 9009936 BACKGROUND

MeSH Terms

Conditions

Ear Neoplasms; Neoplasms

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sébastien Pili Floury, MD, PhD

  CHRU Besançon

  PRINCIPAL INVESTIGATOR

• Angéline Chopard-Guillemin, MD

  CHRU Besançon

  PRINCIPAL INVESTIGATOR

• Amélie Jurine, MD

  CHRU Besançon

  PRINCIPAL INVESTIGATOR

• Guillaume Besch, MD

  CHRU Besançon

  PRINCIPAL INVESTIGATOR

• Arnaud Causeret, MD

  CHRU Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: March 20, 2014
• Study Start: June 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 20, 2014

Record last verified: 2008-11

Locations

FR (2)