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Completed

NCT Number: NCT01038882

Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy

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.

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Key information

Conditions

Sedation Anxiety Anxiety Disorders Behavior Mental Disorders Personal Satisfaction Satisfaction Tolerance

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universaitario La Fe

Valencia, 46009, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

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

physiological serum

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Fe

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 24, 2009
Registry last updated
Dec 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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