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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00392522
Enrollment
64
Registered
2006-10-26
Start date
2006-11-30
Completion date
Unknown
Last updated
2007-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fiberoptic Bronchoscopy

Keywords

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

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.

Interventions

DRUG50% Nitrous Oxide and 50% Oxygen (MEOPA)

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Efficacy in term of pain control Visual Analogic Scale

Secondary

MeasureTime frame
anxiety control (COVI Scale)
cough
number of general anaesthesias

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026