50% Nitrous Oxide and 50% Oxygen (MEOPA) Conscious Sedation Versus Placebo in Fiberoptic Bronchoscopy
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fiberoptic Bronchoscopy |
Drug: 50% Nitrous Oxide and 50% Oxygen (MEOPA) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 50% Nitrous Oxide and 50% Oxygen (MEOPA) Conscious Sedation Versus Placebo in Fiberoptic Bronchoscopy : Randomized, Double Blind, Placebo-Controlled Study |
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00392522 History of Changes |
| Other Study ID Numbers: | 2004.417 |
| Study First Received: | October 25, 2006 |
| Last Updated: | October 4, 2007 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hospices Civils de Lyon:
|
Anxiety Cough Number of general anaesthesias (due to procedure failure) Patients satisfaction Chest physician satisfaction |
Additional relevant MeSH terms:
|
Nitrous Oxide Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on June 17, 2013