Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario La Fe
ClinicalTrials.gov Identifier:
NCT01038882
First received: December 22, 2009
Last updated: December 23, 2009
Last verified: March 2009
  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

Resource links provided by NLM:


Further study details as provided by Hospital Universitario La Fe:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038882

Locations
Spain
Hospital Universaitario La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
Hospital Universitario La Fe
Investigators
Principal Investigator: ENRIQUE CASES-VIEDMA, MD AGENCIA VALENCIANA DE SALUD
  More 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 July 28, 2014