Clinical trial NCT01038882: Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy
Official title: MIDAZOLAM EFFECTIVENESS TO THE SEDATION IN FLEXIBLE BRONCHOSCOPY. A RANDOMIZED STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation
Tolerance
Anxiety
Satisfaction
Keywords: sedation
midazolam
flexible bronchoscopy
tolerance
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2009-12-24
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: PATIENTS AND METHODS:

A randomized, prospective study has been carried out; double blind and controlled with placebo to be treated with midazolam. This included 152 patients, randomized into two groups: Group A - 79(51.9%) patients which received midazolam before the FB, and Group B - (49.1%) patients which received placebo. The patients were given a questionaire of 13 questions about different aspects of perception of the procedure after the respiratory endoscopy and another was given to the Bronchoscopist.

RESULTS:

Both groups started off with a similar assessment of fear and nervousness before the FB. Nevertheless, Group A gave a much higher score than Group B referring to variables related to symptoms and feeling. The patients´ cooperation was assessed by the Bronchoscopist in a similar way in both groups, although the length of the procedure and difficulty was higher in the group treated with placebo (Group B).

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: February 2009
Secondary outcomes:
measure: 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
timeFrame: February 2009
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universaitario La Fe
Study officials:
affiliation: AGENCIA VALENCIANA DE SALUD
name: ENRIQUE CASES-VIEDMA, MD
role: PRINCIPAL_INVESTIGATOR
References:
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