Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392522
Status:
UNKNOWN
Last Update Posted:
2007-10-05
First Post:
2006-10-25
Brief Title:
50 Nitrous Oxide and 50 Oxygen MEOPA Conscious Sedation Versus Placebo in Fiberoptic Bronchoscopy
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
50 Nitrous Oxide and 50 Oxygen MEOPA Conscious Sedation Versus Placebo in Fiberoptic Bronchoscopy Randomized Double Blind Placebo-Controlled Study
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None