Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy
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Purpose
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 | Intervention |
|---|---|
|
Sedation Tolerance Anxiety Satisfaction |
Drug: Midazolam Other: Physiological serum |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) |
| Official Title: | MIDAZOLAM EFFECTIVENESS TO THE SEDATION IN FLEXIBLE BRONCHOSCOPY. A RANDOMIZED STUDY |
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 238 |
| Study Start Date: | October 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Midazolam
The patients of this arma receives midazolam before the flexible bronchoscopy to maintain conscious sedation
|
Drug: Midazolam
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
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | ENRIQUE CASES VIEDMA, GENERALIDAD VALENCIANA. AGENCIA VALENCIANA DE SALUD |
| ClinicalTrials.gov Identifier: | NCT01038882 History of Changes |
| Other Study ID Numbers: | HLaFe 324/08 |
| Study First Received: | December 22, 2009 |
| Last Updated: | December 23, 2009 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by Hospital Universitario La Fe:
|
sedation midazolam flexible bronchoscopy tolerance |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Midazolam Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013