Anxiety Clinical Trial
Official title:
MIDAZOLAM EFFECTIVENESS TO THE SEDATION IN FLEXIBLE BRONCHOSCOPY. A RANDOMIZED STUDY
Verified date | March 2009 |
Source | Hospital Universitario La Fe |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Comité Ético de Investigación Clínica |
Study type | Interventional |
The Flexible Bronchoscopy (FB) is a diagnostic and therapeutic procedure which is not
usually tolerated by the patient. This makes the examination more difficult and a repetition
of the examination, if necessary, resulting in a lower diagnostic performance.
Furthermore, there is nowadays little information with a highly obvious level about the
relationship between sedation and the patient´s satisfaction with the FB.
Midazolam is one of the most commonly used sedatives at the beginning for its rapid onset
property and brief duration of action with sedatives, anxiolytics and amnesia properties.
The principal aim of our study is to analyse if the use of a local anaesthetic with
midazolam whilst performing an FB improves the quality of examination in terms of tolerance
for the patient. It would also be of interest to know if there is an improvement in the
acceptance of a second or further FB and if this improves the satisfaction of the
Bronchoscopist as far as the examination performed is concerned.
Status | Completed |
Enrollment | 238 |
Est. completion date | January 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients referred for diagnostic flexible bronchoscopy - American Society of Anaesthesiology (ASA) class of risk I to III Exclusion Criteria: - Patients undergoing flexible bronchoscopy procedures such advanced techniques (autofluorescence, NBI, endobronchial ultrasound (EBUS)...) - Psychological disorders - Hypersensitivity to benzodiazepine - Severe chronic obstructive pulmonary disease (FEV1 < 50% predicted value, requirement for oxygen therapy - Unstable haemodynamic status (defined as a heart rate < 60 or > 120 and/or a systolic blood pressure < 100 or > 180 mmHG) - Sings of systemic or pulmonary infection |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universaitario La Fe | Valencia |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario La Fe |
Spain,
González R, De-La-Rosa-Ramírez, Maldonado-Hernández A, Domínguez-Cherit G. Should patients undergoing a bronchoscopy be sedated? Acta Anaesthesiol Scand 2003; 47: 411-5. Pérez Negrin LM, Batista Martín JJ, Acosta Fernández O, Trujillo Castilla JL, Gonzalv
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To analyse if the use of a local anaesthetic with midazolam whilst performing an flexible bronchoscopy improves the quality of examination in terms of tolerance for the patient | February 2009 | Yes | |
Secondary | To know if there is an improvement in the acceptance of a second or further flexible bronchoscopy and if this improves the satisfaction of the bronchoscopist as far as the examination performed is concerned | February 2009 | Yes |
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