Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01038882
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : December 24, 2009
Information provided by:
Hospital Universitario La Fe

Brief 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.

Condition or disease Intervention/treatment Phase
Sedation Tolerance Anxiety Satisfaction Drug: Midazolam Other: Physiological serum Not Applicable

Detailed Description:


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Study Start Date : October 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01038882

Hospital Universaitario La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
Hospital Universitario La Fe

Publications of Results:
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, Gonzalvo Hernández F. Subjetive tolerance to flexible bronchoscopy. Journal of Bronchology 2001; 8: 166-9. Ruiz López FJ, Valdivia Salas MM, Latour Pérez J, Ros Lucas LA, Fernández Suarez B, Sánchez Gascón F, Lorenzo Cruz M. Flexible bronchoscopy with only topical anesthesia. J Bronchol 2006; 13: 54-7. Stolz D, Prashant NC, Leuppi J, Pflimlin E, Tamm M. Nebulized lidocaine for flexible bronchoscopy: A randomized, double-blind, placebo-controlled trial. Chest 2005; 128: 1756-60. Honeybourne D, Babb J, Bowie P, Brewin A, Fraise A, Garrard C, Harvey J, Lewis R, Neumann C, Wathen CG, Williams T. British Thoracic Society guidelines on diagnostic flexible bronchoscopy. Thorax 2001; 56:(suppl I) i1-i21. Houghton CM, Raghuram A, Sullivan PJ, O´Driscoll R. Pre-medication for bronchoscopy: a randomised double blind trial comparing alfetanil with midazolam. Respir Med 2004; 98: 1102-7. Clark G, Licker M, Younossian AB, Soccal PM, Frey JG, Rochat T, Diaper J, Bridevaux PO, Tschopp JM. Titrated sedation with propofol or midazolam for flexible bronchoscopy: a randomised trial. Eur Respir J. 2009; 34: 1277-83. Stolz D, Kurer G, Meyer A, Chhajed PN, Pflimlin E, Strobel W, Tamm M. Propofol versus combined sedation in flexible bronchoscopy: a randomised non-inferiority trial. Eur Respir J. 2009; 34: 1024-30. Stolz D, Chhajed PN, Leuppi JD, Brutsche M, Pflimlin E, Tamm M. Cough suppression during flexible bronchoscopy using combined sedation with midazolam an hydrocodone: a randomised, double blind, placebo controlled trial. Thorax 2004; 59: 773-6. Chhajed PN, Wallner J, Stolz D, Baty F, Strobel W, Brutsche MH, Tamm M. Sedative drug requirements during flexible bronchoscopy. Respiration 2005; 72: 617-21.

Other Study ID Numbers: HLaFe 324/08
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: December 24, 2009
Last Verified: March 2009

Keywords provided by Hospital Universitario La Fe:
flexible bronchoscopy

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action