Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy
|ClinicalTrials.gov Identifier: NCT01038882|
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : December 24, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Sedation Tolerance Anxiety Satisfaction||Drug: Midazolam Other: Physiological serum||Not Applicable|
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.
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||MIDAZOLAM EFFECTIVENESS TO THE SEDATION IN FLEXIBLE BRONCHOSCOPY. A RANDOMIZED STUDY|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
Active Comparator: Midazolam
The patients of this arma receives midazolam before the flexible bronchoscopy to maintain conscious sedation
Sedation started by injecting a 4 ml drug bolus with midazolam (0.07-0.1 mg/kg dose). Supplemental doses of midazolam (2 mg) were administrated at an interval of >2 min to maintain conscious sedation
|Placebo Comparator: Physiological serum||
Other: Physiological serum
We started by injecting a 4 ml drug bolus and we ad supplemental doses (2 ml) to maintain the conscious sedation
- 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 [ Time Frame: February 2009 ]
- 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 [ Time Frame: February 2009 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038882
|Hospital Universaitario La Fe|
|Valencia, Spain, 46009|
|Principal Investigator:||ENRIQUE CASES-VIEDMA, MD||AGENCIA VALENCIANA DE SALUD|