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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

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.

Detailed Description

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Conditions

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Fiberoptic Bronchoscopy

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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50% Nitrous Oxide and 50% Oxygen (MEOPA)

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Corinne DEPAGNE, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Corinne Depagne

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2004.417

Identifier Type: -

Identifier Source: org_study_id