SedationNCT01038882
Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy
A study testing Midazolam and Physiological serum in people with Sedation and Tolerance, run by Hospital Universitario La Fe at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Midazolam and Physiological serum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2008to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for diagnostic flexible bronchoscopy
- American Society of Anaesthesiology (ASA) class of risk I to III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MIDAZOLAM EFFECTIVENESS TO THE SEDATION IN FLEXIBLE BRONCHOSCOPY. A RANDOMIZED STUDY
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.
Read more
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.
Read the 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
- Being tested
- Midazolam, Physiological serum
- Keywords
- sedation, midazolam, flexible bronchoscopy, tolerance
- Medical subject headings
- Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
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 serumOther
We started by injecting a 4 ml drug bolus and we ad supplemental doses (2 ml) to maintain the conscious sedation
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Active comparator | The patients of this arma receives midazolam before the flexible bronchoscopy to maintain conscious sedation Receives: Drug: Midazolam |
| Physiological serum | Placebo comparator | Not described Receives: Other: Physiological serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: February 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startOct 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Investigators
- ENRIQUE CASES-VIEDMA, MD, Principal investigator, AGENCIA VALENCIANA DE SALUD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038882
- Sponsor's protocol ID
- HLaFe 324/08
- Status last verified
- Mar 2009
- First submitted
- 22 Dec 2009
- Last updated
- 24 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIDAZOLAM EFFECTIVENESS TO THE SEDATION IN FLEXIBLE BRONCHOSCOPY. A RANDOMIZED STUDY
- ClinicalTrials.gov ID
- NCT01038882
- Acronym / sponsor ID
- HLaFe 324/08
- Conditions
- Sedation, Tolerance, Anxiety, Satisfaction
- Keywords
- sedation, midazolam, flexible bronchoscopy, tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Active comparator | Drug: MidazolamThe patients of this arma receives midazolam before the flexible bronchoscopy to maintain conscious sedation |
| Physiological serum | Placebo comparator | Other: Physiological serum |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred for diagnostic flexible bronchoscopy
- American Society of Anaesthesiology (ASA) class of risk I to III
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamSedation 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 | Drug | Midazolam |
| Physiological serumWe started by injecting a 4 ml drug bolus and we ad supplemental doses (2 ml) to maintain the conscious sedation | Other | Physiological serum |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
- Results publicationGonzález 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ENRIQUE CASES-VIEDMA, MD principal investigator
AGENCIA VALENCIANA DE SALUD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam and Physiological serum in people with Sedation and Tolerance, run by Hospital Universitario La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01038882, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2009.