50% Nitrous Oxide and 50% Oxygen (MEOPA) Conscious Sedation Versus Placebo in Fiberoptic Bronchoscopy

NCT00392522 | Unknown Phase 3

• 1 other identifier: 2004.417
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Fiberoptic bronchoscopy may generate pain, anxiety or cough and dyspnea. It may then induce discomfort and then run down its yield. Systematic local anaesthesia does not always suffice and FOB may be conducted under general anaesthesia. Premixed nitrous oxide and oxygen (MEOPA) could be efficient to avoid general anesthesia risks and to reduce organizational costs. Nitrous oxide induces anaelgesia and anxiolysis when administered in oxygen at a 50% concentration. MEOPA is being delivered in France for every short painful medical in-patients procedure since 2001. At a concentration of 50% in oxygen, and delivered through a facial mask, it produces a conscious sedation useful during endoscopy. MEOPA safety is due to its short term effect, which ends 5 minutes after cessation of inhalation. It therefore allows ambulatory medicine. Two randomized double blind controlled studies were driven in fiberoptic bronchoscopy (Fauroux 2004, Atassi 2005) and showed its efficacy on pain control and sedation. We will perform our Study to estimate MEOPA efficacy in term of pain control (Visual Analogic Scale (VAS)), anxiety control (COVI Scale), cough and number of general anaesthesias, comparing FOB under MEOPA and Oxygen (double blind, randomized, placebo-controlled study.

Conditions

Fiberoptic Bronchoscopy

Keywords

Anxiety; Cough; Number of general anaesthesias (due to procedure failure); Patients satisfaction; Chest physician satisfaction

Outcome Measures

Primary Outcomes (1)

• Efficacy in term of pain control Visual Analogic Scale

Secondary Outcomes (3)

• anxiety control (COVI Scale)

• cough

• number of general anaesthesias

Interventions

50% Nitrous Oxide and 50% Oxygen (MEOPA) DRUG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman over 18 who should undergo a fiberoptic bronchoscopy (inpatient and outpatient)

You may not qualify if:

• Child under 18
• Pneumothorax
• ocular surgery in the previous 3 months,
• intracranial overpressure
• lucidity impairment
• emphysema bullae
• face trauma
• angina pectoris
• hemodynamic instability
• acute respiratory distress
• hypercapnia \> 45 mm Hg
• pregnancy
• lidocaine allergia
• lack of approuval from the patient to perform the study will of the patient to undergo FOB with premixed nitrous oxide-oxygen

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Corinne Depagne

Lyon, 69004, France

Location

MeSH Terms

Conditions

Anxiety Disorders; Cough

Interventions

Nitrous Oxide; Oxygen; Meopa

Condition Hierarchy (Ancestors)

Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements

Study Officials

• Corinne DEPAGNE, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 25, 2006
• First Posted: October 26, 2006
• Study Start: November 1, 2006
• Last Updated: October 5, 2007

Record last verified: 2007-10

Locations

FR (1)