Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy

NCT ID: NCT01038882

Last Updated: 2009-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-01-31

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.

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).

Conditions

Sedation; Tolerance; Anxiety; Satisfaction

Keywords

sedation; midazolam; flexible bronchoscopy; tolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Midazolam

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

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Physiological serum

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DRUG

Physiological serum

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario La Fe

OTHER

Sponsor Role: lead

Responsible Party

GENERALIDAD VALENCIANA. AGENCIA VALENCIANA DE SALUD

Principal Investigators

ENRIQUE CASES-VIEDMA, MD

Role: PRINCIPAL_INVESTIGATOR

AGENCIA VALENCIANA DE SALUD

Locations

Hospital Universaitario La Fe

Valencia, Valencia, Spain

Countries

Spain

References

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.

Reference Type: RESULT

Other Identifiers

HLaFe 324/08

Identifier Type: -

Identifier Source: org_study_id