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

Fiberoptic Bronchoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00392522
• Other study ID #: 2004.417
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 25, 2006
• Last updated: October 4, 2007
• Start date: November 2006

Study information

• Verified date: October 2007
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Fiberoptic Bronchoscopy

Intervention

Drug:
• 50% Nitrous Oxide and 50% Oxygen (MEOPA)

Locations

Country	Name	City	State
France	Corinne Depagne	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy in term of pain control Visual Analogic Scale
Secondary	anxiety control (COVI Scale)
Secondary	cough
Secondary	number of general anaesthesias