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

Study Overview
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Brief Summary
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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.

Official Title
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50% Nitrous Oxide and 50% Oxygen (MEOPA) Conscious Sedation Versus Placebo in Fiberoptic Bronchoscopy : Randomized, Double Blind, Placebo-Controlled Study

Conditions
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Fiberoptic Bronchoscopy

Intervention / Treatment
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* Drug: 50% Nitrous Oxide and 50% Oxygen (MEOPA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man or woman over 18 who should undergo a fiberoptic bronchoscopy (inpatient and outpatient) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 50% Nitrous Oxide and 50% Oxygen (MEOPA)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy in term of pain control Visual Analogic Scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety control (COVI Scale) |  |  | 
| cough |  |  | 
| number of general anaesthesias |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Cough, Number of general anaesthesias (due to procedure failure), Patients satisfaction, Chest physician satisfaction