Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy

NCT01038882 | Completed DMC

• 1 other identifier: HLaFe 324/08
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation; Tolerance; Anxiety; Satisfaction

Keywords

sedation; midazolam; flexible bronchoscopy; tolerance

Outcome Measures

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

  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

  February 2009

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

The patients of this arma receives midazolam before the flexible bronchoscopy to maintain conscious sedation

Drug: Midazolam

Physiological serum

PLACEBO COMPARATOR

Other: Physiological serum

Interventions

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

Midazolam

Physiological serum OTHER

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

Physiological serum

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for diagnostic flexible bronchoscopy
• American Society of Anaesthesiology (ASA) class of risk I to III

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (1)

Hospital Universaitario La Fe

Valencia, Valencia, 46009, Spain

Location

Related 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, 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.

  RESULT

MeSH Terms

Conditions

Anxiety Disorders; Personal Satisfaction

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• ENRIQUE CASES-VIEDMA, MD

  AGENCIA VALENCIANA DE SALUD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: October 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 24, 2009

Record last verified: 2009-03

Locations

ES (1)