BronchoscopyPhase 3NCT01805726
Sedation During Bronchoscopy:Dexmedetomidine vs Alfentanil
A Phase 3 study testing xylocain, Alfentanil and Dexmedetomidine in people with Bronchoscopy and Conscious Sedation, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
The purpose of this study is to find the best sedation necessary for patients undergoing bronchoscopy. Patients are randomized to three different regimes of sedation during bronchoscopy were studied: 1. - Group standard/control: local anesthesia only(C) 2. - Group alfentanil + local anesthesia(A) 3. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchoscopy, Conscious Sedation
- What is being tested?
- xylocain, Alfentanil and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteLebanon
- Study dates
- Feb 2013to Nov 2014
- Phase
- Phase 3
- 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
- All patients admitted for diagnostic flexible bronchoscopy in the endoscopy department
Who cannot join
- Bronchoscopy outside the endoscopy unit
- Tracheal stenosis
- SpO2 <90% in the open air
- Bradycardia <55 per minute
- Atrioventricular block
- Heart failure known (EF <40%)
- Alcoholism (> 5 drinks per week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Success of Sedation During Bronchoscopy: Comparison of the Effects of Dexmedetomidine, Alfentanil and Local Anesthesia
The purpose of this study is to find the best sedation necessary for patients undergoing bronchoscopy. Patients are randomized to three different regimes of sedation during bronchoscopy were studied:
- - Group standard/control: local anesthesia only(C)
- - Group alfentanil + local anesthesia(A)
- - Group dexmedetomidine + local anesthesia(D) The primary endpoint is the bronchoscopy score. Secondary endpoints are: Level of sedation and tolerance bronchoscopy examination. Measured parameters on the safety of examination are: the lowest saturation, needs to supplemental oxygen, amnesia , choking sensation or chest pain and if the patient is ready or not to undertake bronchoscopy second time in his life if necessary. Endtidal CO2, Respiratory rate, Blood pressure, Heart rate, level of oxygen are collected every 5 minutes before, during and after the bronchoscopy.
Read the detailed description
BACKGROUND:
- Problem: The endoscopy of the tracheobronchial tree by endoscopy is an act very common in the daily activity of pulmonologists. The indications for bronchoscopy are multiple and include infectious causes, tumor, systemic disease, foreign bodies and other indications. It can be diagnostic or therapeutic purposes. Bronchoscopy is an invasive but rarely, however, induced severe complications (respiratory failure, hemodynamic collapse, massive bleeding ...). However, tolerance to the examination varies significantly between patients [1-3]. Different signs and symptoms include desaturation, chest pain, choking sensation and cough. These effects are likely to alter patient comfort during the procedure and the quality of it. To further improve the tolerance operators have resorted to various techniques. A first step in improving the comfort is a good local anesthesia using spray or swab intra nasal base and lidocaine anesthesia of the airway (trachea, carina and bronchi) during the examination. The second step involves the use of intravenous sedation [1, 3-14].
- Background:
Until now, there is no standardized protocol for the best product and the best dose to use for sedation of patients. Several studies have been done comparing different drug or drug combination in the benzodiazepine family, ketamine or morphine with varying results and not leading in most cases to allow conclusions to establish clear guidelines regarding the use or no sedation plus local anesthesia and sedation dose of this [1, 3, 5, 8, 15]. Especially, for fear of adverse effects of sedation on respiratory function, many pulmonologists far are a little hesitant about the administration of sedatives during bronchoscopy. Dexmedetomidine is a new molecule sedation which is approved for its sedative effect while holding a revival meeting described as "awake sedation." [12, 16-22]
DESCRIPTION:
The aim of this randomized controlled trial was to evaluate the feasibility and safety of three different regimes of sedation during bronchoscopy:
- Group standard / control (local anesthesia only): (C)
- Group alfentanil (+ local anesthesia): (A)
- Group dexmedetomidine (+ local anesthesia): (D)
The primary endpoint is:
- / Feasibility / tolerance of bronchoscopy by the "score bronchoscopy" which includes:
- The movement of the vocal cords (4 levels)
- Cough (4 levels)
- Movement members (4 levels) Secondary objectives:
- / level sedation for bronchoscopy:
- Level of sedation achieved according to the objective using: Nursing Instrument for the Communication of Sedation (NICS) (7 levels).
- Dose of midazolam necessary complementary in each group. Midazolam to give to the judgment of the operator (if necessary) is predetermined speed (1 mg each minute) to the level of sedation (-1) "Level of sedation achieved according to the objective using: Nursing Instrument for the communication of Sedation (NICS)".
- / Tolerance examination:
- During the procedure
- At the end of the procedure
- After 1 hour of the end of the examination
- Conditions
- Bronchoscopy, Conscious Sedation
- Being tested
- xylocain, Alfentanil, Dexmedetomidine
- Keywords
- bronchoscopy, sedation, pulmonary function, tolerance, xylocain, dexmedetomidine, alfentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xylocainDrug
Also called Xylocain only
Xylocain: (C): Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum
AlfentanilDrug
Also called Alfentanil as morphinics short acting
(A) Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum (slow perfusion for 10 minutes) + alfentanil 10 mcg / kg (slow injection in 5 seconds)
DexmedetomidineDrug
Also called Dexmedetomidine as awake sedation
(D) Local anesthesia 1% 25 ml in total (bronchoscopy) + dexmedetomidine 0.5 mcg / kg (slow perfusion for 10 minutes) + 2 ml saline (slow injection for 5 seconds)
| Study group | Role | What they receive |
|---|---|---|
| Xylocain (C) | Placebo comparator | (C): Local anesthesia Receives: Drug: xylocain |
| Alfentanil Group + Xylocain (A) | Active comparator | Local anesthesia and Alfentanil Receives: Drug: Alfentanil |
| Dexmedetomidine Group + Xylocain (D) | Active comparator | Local anesthesia and dexmedetomidine Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchoscopy score
Feasibility / tolerance of bronchoscopy by the "score bronchoscopy" which includes:
- The movement of the vocal cords (4 levels)
- Cough (4 levels)
- Movement members (4 levels) Scale will be between: minimum 3 and maximum 16
Measured: At the end of the bronchoscopy procedure
Secondary outcomes (1)
Level of sedation for bronchoscopy
- Level of sedation achieved according to the objective using: Nursing Instrument for the Communication of Sedation (NICS) (7 levels).
- Dose of midazolam necessary complementary in each group. Dormicum to give to the judgment of the operator (if necessary) is predetermined speed (1 mg each minute) to the level of sedation (-1) "Level of sedation achieved according to the objective using: Nursing Instrument for the communication of Sedation (NICS) "
Measured: At the end of the bronchoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moussa A Riachy, MD, FCCP, Principal investigator, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805726
- Sponsor's protocol ID
- FM235
- Status last verified
- Nov 2014
- First submitted
- 17 Feb 2013
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success of Sedation During Bronchoscopy: Comparison of the Effects of Dexmedetomidine, Alfentanil and Local Anesthesia
- ClinicalTrials.gov ID
- NCT01805726
- Acronym / sponsor ID
- FM235
- Conditions
- Bronchoscopy, Conscious Sedation
- Keywords
- bronchoscopy, sedation, pulmonary function, tolerance, xylocain, dexmedetomidine, alfentanil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 6 Mar 2013 (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 purpose of this study is to find the best sedation necessary for patients undergoing bronchoscopy. Patients are randomized to three different regimes of sedation during bronchoscopy were studied:
- - Group standard/control: local anesthesia only(C)
- - Group alfentanil + local anesthesia(A)
- - Group dexmedetomidine + local anesthesia(D) The primary endpoint is the bronchoscopy score. Secondary endpoints are: Level of sedation and tolerance bronchoscopy examination. Measured parameters on the safety of examination are: the lowest saturation, needs to supplemental oxygen, amnesia , choking sensation or chest pain and if the patient is ready or not to undertake bronchoscopy second time in his life if necessary. Endtidal CO2, Respiratory rate, Blood pressure, Heart rate, level of oxygen are collected every 5 minutes before, during and after the bronchoscopy.
Detailed description
BACKGROUND:
- Problem: The endoscopy of the tracheobronchial tree by endoscopy is an act very common in the daily activity of pulmonologists. The indications for bronchoscopy are multiple and include infectious causes, tumor, systemic disease, foreign bodies and other indications. It can be diagnostic or therapeutic purposes. Bronchoscopy is an invasive but rarely, however, induced severe complications (respiratory failure, hemodynamic collapse, massive bleeding ...). However, tolerance to the examination varies significantly between patients [1-3]. Different signs and symptoms include desaturation, chest pain, choking sensation and cough. These effects are likely to alter patient comfort during the procedure and the quality of it. To further improve the tolerance operators have resorted to various techniques. A first step in improving the comfort is a good local anesthesia using spray or swab intra nasal base and lidocaine anesthesia of the airway (trachea, carina and bronchi) during the examination. The second step involves the use of intravenous sedation [1, 3-14].
- Background:
Until now, there is no standardized protocol for the best product and the best dose to use for sedation of patients. Several studies have been done comparing different drug or drug combination in the benzodiazepine family, ketamine or morphine with varying results and not leading in most cases to allow conclusions to establish clear guidelines regarding the use or no sedation plus local anesthesia and sedation dose of this [1, 3, 5, 8, 15]. Especially, for fear of adverse effects of sedation on respiratory function, many pulmonologists far are a little hesitant about the administration of sedatives during bronchoscopy. Dexmedetomidine is a new molecule sedation which is approved for its sedative effect while holding a revival meeting described as "awake sedation." [12, 16-22]
DESCRIPTION:
The aim of this randomized controlled trial was to evaluate the feasibility and safety of three different regimes of sedation during bronchoscopy:
- Group standard / control (local anesthesia only): (C)
- Group alfentanil (+ local anesthesia): (A)
- Group dexmedetomidine (+ local anesthesia): (D)
The primary endpoint is:
- / Feasibility / tolerance of bronchoscopy by the "score bronchoscopy" which includes:
- The movement of the vocal cords (4 levels)
- Cough (4 levels)
- Movement members (4 levels) Secondary objectives:
- / level sedation for bronchoscopy:
- Level of sedation achieved according to the objective using: Nursing Instrument for the Communication of Sedation (NICS) (7 levels).
- Dose of midazolam necessary complementary in each group. Midazolam to give to the judgment of the operator (if necessary) is predetermined speed (1 mg each minute) to the level of sedation (-1) "Level of sedation achieved according to the objective using: Nursing Instrument for the communication of Sedation (NICS)".
- / Tolerance examination:
- During the procedure
- At the end of the procedure
- After 1 hour of the end of the examination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Xylocain (C) | Placebo comparator | Drug: xylocain(C): Local anesthesia |
| Alfentanil Group + Xylocain (A) | Active comparator | Drug: AlfentanilLocal anesthesia and Alfentanil |
| Dexmedetomidine Group + Xylocain (D) | Active comparator | Drug: DexmedetomidineLocal anesthesia and dexmedetomidine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted for diagnostic flexible bronchoscopy in the endoscopy department
Key exclusion criteria (7 listed)
- Bronchoscopy outside the endoscopy unit
- Tracheal stenosis
- SpO2 <90% in the open air
- Bradycardia <55 per minute
- Atrioventricular block
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 |
|---|---|---|
| xylocainAlso: Xylocain onlyXylocain: (C): Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum | Drug | Xylocain (C) |
| AlfentanilAlso: Alfentanil as morphinics short acting(A) Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum (slow perfusion for 10 minutes) + alfentanil 10 mcg / kg (slow injection in 5 seconds) | Drug | Alfentanil Group + Xylocain (A) |
| DexmedetomidineAlso: Dexmedetomidine as awake sedation(D) Local anesthesia 1% 25 ml in total (bronchoscopy) + dexmedetomidine 0.5 mcg / kg (slow perfusion for 10 minutes) + 2 ml saline (slow injection for 5 seconds) | Drug | Dexmedetomidine Group + Xylocain (D) |
Primary outcome
Bronchoscopy score
Time frame: At the end of the bronchoscopy procedure
Feasibility / tolerance of bronchoscopy by the "score bronchoscopy" which includes: * The movement of the vocal cords (4 levels) * Cough (4 levels) * Movement members (4 levels) Scale will be between: minimum 3 and maximum 16
1 secondary outcome
Level of sedation for bronchoscopy
Time frame: At the end of the bronchoscopy procedure
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 25 Nov 2014.
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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.
Moussa A Riachy, MD, FCCP principal investigator
Saint-Joseph University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing xylocain, Alfentanil and Dexmedetomidine in people with Bronchoscopy and Conscious Sedation, run by Saint-Joseph University at 1 site in Lebanon.
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 1 inclusion and 7 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 25 Nov 2014. 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 Lebanon. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bronchoscopy score (time frame: At the end of the bronchoscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2014.