Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy

Anxiety Clinical Trial

Official title:

MIDAZOLAM EFFECTIVENESS TO THE SEDATION IN FLEXIBLE BRONCHOSCOPY. A RANDOMIZED STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038882
• Other study ID #: HLaFe 324/08
• Status: Completed
• Phase: N/A
• First received: December 22, 2009
• Last updated: December 23, 2009
• Start date: October 2008
• Est. completion date: January 2009

Study information

• 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

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Anxiety
• Satisfaction
• Sedation
• Tolerance

Intervention

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

Other:
• Physiological serum
We started by injecting a 4 ml drug bolus and we ad supplemental doses (2 ml) to maintain the conscious sedation

Locations

Country	Name	City	State
Spain	Hospital Universaitario La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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

Outcome

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