Realisation of Bronchial FibroscopyPhase 4REVPRONCT01872754
Study Comparing the Use of Remifentanil Versus Propofol for Performing Bronchial Fibroscopy
A Phase 4 study testing 1: Remifentanil and 2: Propofol in people with Realisation of Bronchial Fibroscopy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine whether the use of Target-Controlled Infusion (TCI) of Remifentanil can deliver better conditions for performing bronchial fibroscopy with spontaneous ventilation (decrease the duration of cough) compared to the use of TCI of Propofol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Realisation of Bronchial Fibroscopy
- What is being tested?
- 1: Remifentanil and 2: Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2013to 3 Apr 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient major with consent
- Patient with an indication of bronchoscopy under intravenous sedation:
- Cough making endoscopy impossible despite local anesthesia
- Refusal of the patient to undergo the action without sedation
- There is no limitation related to the type of pathology: it is patient "all comers"
Who cannot join
- Patients with a known allergy to Remifentanil
- Patients with a known allergy to Propofol, soy, peanuts
- Pregnant women or nursing
- Neurological pathology causing intracranial hypertension
- Patients with a Body Mass Index greater than 30
- Indications of orotracheal intubation :
Show all 10Show fewer
- Protection of the upper airways: patient considered "full stomach": Diabetes with autonomic dysfunction, severe gastroesophageal reflux, severe obesity and morbid hiatal hernia and any other situation governed by the anesthesiologist as a situation of full stomach
- The need for mechanical ventilation severe hypoxemia
- Cirrhosis child B and C
- Intermittent or severe uncontrolled asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized and Single Blind Study Comparing Remifentanil Sedation Versus Propofol for Performing Bronchial Fibroscopies Under Intravenous Anesthesia
The purpose of this study is to determine whether the use of Target-Controlled Infusion (TCI) of Remifentanil can deliver better conditions for performing bronchial fibroscopy with spontaneous ventilation (decrease the duration of cough) compared to the use of TCI of Propofol.
Read the detailed description
Patients with an indication of bronchoscopy under sedation with spontaneous ventilation will be prospectively included in the study.
The proposal for inclusion is presented by the anesthetist performing the anesthetic consultation. Consent form and explanatory notes are given to the patient. The patient has a period of reflection of at least 48 hours in the case of a scheduled endoscopy for signing the consent. For urgent cases a period of 24 hours will be accepted. The patient is informed that the proceedings will be recorded to allow the calculation of the total number of coughing episodes and their duration.
- V-1: Inclusion visit in post-interventional care unit.
- Check the indication of endoscopy and sedation.
- Verification of inclusion and non-inclusion criteria.
- Obtention of signed consent from the patient and inclusion in the study.
- Randomization : The degree of patient anxiety using a visual analogue scale (VAS) and the operator's experience (the number of years of practice) are required for stratification.
- Collection of epidemiological data
- V0: Bronchial Fibroscopy.
- Installation of the patient
- To ensure operator blindness with respect to the type of drug used (remifentanil versus propofol) for the sedation, the tubing and syringe are hidden by a operative drape. The person collecting the data will also blind to the drug used.
- Oxygen (6l / min) is administred to the patient using a high concentration oxygen mask with an End-tidal CO2.
- Collection of basic constants (SBP and DBP, HR, RR, SpO2, EtCO2, OAAS score) prior to anesthesia.
- 5 sprays of lidocaine 50 mg / ml are administred in each nostril.
- Collection of constants during endoscopy under anesthesia (SBP and DBP, HR, RR, SpO2, EtCO2, OAAS score every minute for the total duration of endoscopy) and the occurrence of cough by sound digital recording. The duration and number of episodes of coughing will be timed retrospectively from the sound recording.
- Concentration at target effect site is recorded every minute
- The total dose of lidocaine 10 mg / ml instilled by the operator is recorded. The total dose does not exceed 200 mg.
- Vital signs (SBP and DBP, HR, RR, SpO2, EtCO2), the total duration of the endoscopy and the number of episodes of coughing by sound recording, OAAS score, the target concentrations at effect site, the type of procedure performed (LBA, biopsies...) and adverse events are collected.
- V1: Visit of end of endoscopy. Satisfaction of the fibroscopist is collected by questionnaire in two areas: the quality of endoscopy in three items (quality of visualization of the tracheobronchial tree, review performance, and ease of progression), and the quality of sedation in three items (interference due to patient movement, coughing related incidents and those linked to the actions of the anesthetist). Each item is measured using a Likert scale of 5 points.
- V2 : Visit of end of study. Patient satisfaction is collected in 3 areas: collecting the degree of inconvenience in three items (pain, memory and cough), the degree of discomfort three items (during local anesthesia, during insertion of the endoscope, and during the exploration of the tracheobronchial tree), and the degree of acceptance to repeat the examination in the future. Each item is measured using a Likert scale of 5 points.
- V3 : patient status. Day 7, patient satisfaction is collected by phone contact or directly if the patient is still in hospital.Patient satisfaction is collected in 3 areas: collecting the degree of inconvenience in three items (pain, memory and cough), the degree of discomfort three items (during insertion of the endoscope, during the exploration of the tracheobronchial tree), and the degree of acceptance to repeat the examination in the future. Each item is measured using a Likert scale of 5 points.
- Effective calculation. We evaluated two strategies for sedation during a preliminary study of 45 patients (Gaillard, SRLF 2010 summary 003940). Cough of more than 10 seconds occurred in 76% of patients sedated with propofol and 32% of patients sedated with Remifentanil. From these data, A number of N = 71 patients will have a power of 80% to demonstrate a difference by Fisher exact probability test between two groups of 35% of percentage of cough of more than 10 secondes.
- Statistical analysis. The primary endpoint and secondary endpoints will be analyzed by qualitative test of Mantel-Haentzel. The homogeneity of odds ratios (existence of a significant level of anxiety) will be tested by the Breslow-Day.Comparing the duration of each examination, the dose of lidocaine instilled, satisfaction scores and the number of increments and decrements in both groups will be made by Mann-Whitney test. For these variables, the possible interactions between the type of action and treatment are analyzed in a ANOVA model.
The duration of recruitment is 45 months.
- Conditions
- Realisation of Bronchial Fibroscopy
- Being tested
- 1: Remifentanil, 2: Propofol
- Keywords
- Bronchial fibroscopy, Remifentanil, Propofol, Sedation, Target Controlled Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1: RemifentanilDrug
1: Remifentanil group The infusion of Remifentanil by TCI begins at distance from the introduction of fiberoptic. The effect site target is 4 ng / ml.- A titration in increments or decrements (respectively increase or decrease of 1 ng / ml effect site concentration) separated by 1 minute intervals until an OAAS score of 4 and respiratory frequency range between 10 and 20 cycles per minute.
2: PropofolDrug
2: Propofol group- The infusion of Propofol by TCI begins at distance from the introduction of fiberoptic. The effect site target is 2,5 ng / ml.- A titration in increments or decrements (respectively increase or decrease of 0.5 mg / ml concentration effect site) separated by 1 minute intervals until an OAAS score of 4 and included respiratory rate between 10 and 20 cycles per minute.
| Study group | Role | What they receive |
|---|---|---|
| 2: Propofol | Active comparator | Control arm: the use of TCI of hypnotic (Propofol) during realization bronchial fibroscopy. Receives: Drug: 2: Propofol |
| 1: Remifentanil | Experimental | Interventional arm: the use of TCI of morphinomimetic (Remifentanil) during realization bronchial fibroscopy. Receives: Drug: 1: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of patient's caught
Comparison of the duration of patient's caught during realisation of bronchial fibroscopy according to type of performed sedation (remifentanil versus propofol
Measured: at day0
Secondary outcomes (5)
Respiratory frequence and Gaz volume
Compare treatment modalities in terms of side effects (remifentanil versus propofol): initial values, maximum and minimum EtCO2 score, the occurrence of desaturation of more than 3 points compared to baseline in 6 l / min oxygen mask, the occurrence of bradypnea with respiratory rate less than 8 / minute, the occurrence of upper airway obstruction and a inhalation salivary.
Measured: Day0
Fibroscopist's satisfaction
Compare treatment modalities in terms of satisfaction for fibroscopist in 2 areas: the quality of fibroscopy and quality of sedation.
Measured: Day0
Patient's satisfaction
Compare treatment modalities in terms of satisfaction to the patient in 3 areas: collecting the degree of inconvenience, the degree of discomfort and the degree of acceptance to repeat the examination in the future.
Measured: Day0
Pharmacodynamics
Compare treatment modalities in terms pharmacodynamics: target concentrations were collected on initial site effect, maximum and average, as well as the rate received per minute and the total dose.
Measured: Day0
Number of episodes of cough
Compare the number of episodes of cough according to the type of sedation used
Measured: Day0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study start31 Jul 2013
- Primary completion3 Apr 2017
- Study completion3 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Realisation of Bronchial FibroscopyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique J MAUREL, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872754
- Sponsor's protocol ID
- P090803
- Other IDs
- 2011-005175-17
- Acronym
- REVPRO
- Status last verified
- May 2017
- First submitted
- 5 Jun 2013
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized and Single Blind Study Comparing Remifentanil Sedation Versus Propofol for Performing Bronchial Fibroscopies Under Intravenous Anesthesia
- ClinicalTrials.gov ID
- NCT01872754
- Acronym / sponsor ID
- REVPRO / P090803
- Conditions
- Realisation of Bronchial Fibroscopy
- Keywords
- Bronchial fibroscopy, Remifentanil, Propofol, Sedation, Target Controlled Infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 31 Jul 2013 (actual)
- Primary completion
- 3 Apr 2017 (actual)
- Study completion
- 3 Apr 2017 (actual)
- First posted
- 7 Jun 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 determine whether the use of Target-Controlled Infusion (TCI) of Remifentanil can deliver better conditions for performing bronchial fibroscopy with spontaneous ventilation (decrease the duration of cough) compared to the use of TCI of Propofol.
Detailed description
Patients with an indication of bronchoscopy under sedation with spontaneous ventilation will be prospectively included in the study.
The proposal for inclusion is presented by the anesthetist performing the anesthetic consultation. Consent form and explanatory notes are given to the patient. The patient has a period of reflection of at least 48 hours in the case of a scheduled endoscopy for signing the consent. For urgent cases a period of 24 hours will be accepted. The patient is informed that the proceedings will be recorded to allow the calculation of the total number of coughing episodes and their duration.
- V-1: Inclusion visit in post-interventional care unit.
- Check the indication of endoscopy and sedation.
- Verification of inclusion and non-inclusion criteria.
- Obtention of signed consent from the patient and inclusion in the study.
- Randomization : The degree of patient anxiety using a visual analogue scale (VAS) and the operator's experience (the number of years of practice) are required for stratification.
- Collection of epidemiological data
- V0: Bronchial Fibroscopy.
- Installation of the patient
- To ensure operator blindness with respect to the type of drug used (remifentanil versus propofol) for the sedation, the tubing and syringe are hidden by a operative drape. The person collecting the data will also blind to the drug used.
- Oxygen (6l / min) is administred to the patient using a high concentration oxygen mask with an End-tidal CO2.
- Collection of basic constants (SBP and DBP, HR, RR, SpO2, EtCO2, OAAS score) prior to anesthesia.
- 5 sprays of lidocaine 50 mg / ml are administred in each nostril.
- Collection of constants during endoscopy under anesthesia (SBP and DBP, HR, RR, SpO2, EtCO2, OAAS score every minute for the total duration of endoscopy) and the occurrence of cough by sound digital recording. The duration and number of episodes of coughing will be timed retrospectively from the sound recording.
- Concentration at target effect site is recorded every minute
- The total dose of lidocaine 10 mg / ml instilled by the operator is recorded. The total dose does not exceed 200 mg.
- Vital signs (SBP and DBP, HR, RR, SpO2, EtCO2), the total duration of the endoscopy and the number of episodes of coughing by sound recording, OAAS score, the target concentrations at effect site, the type of procedure performed (LBA, biopsies...) and adverse events are collected.
- V1: Visit of end of endoscopy. Satisfaction of the fibroscopist is collected by questionnaire in two areas: the quality of endoscopy in three items (quality of visualization of the tracheobronchial tree, review performance, and ease of progression), and the quality of sedation in three items (interference due to patient movement, coughing related incidents and those linked to the actions of the anesthetist). Each item is measured using a Likert scale of 5 points.
- V2 : Visit of end of study. Patient satisfaction is collected in 3 areas: collecting the degree of inconvenience in three items (pain, memory and cough), the degree of discomfort three items (during local anesthesia, during insertion of the endoscope, and during the exploration of the tracheobronchial tree), and the degree of acceptance to repeat the examination in the future. Each item is measured using a Likert scale of 5 points.
- V3 : patient status. Day 7, patient satisfaction is collected by phone contact or directly if the patient is still in hospital.Patient satisfaction is collected in 3 areas: collecting the degree of inconvenience in three items (pain, memory and cough), the degree of discomfort three items (during insertion of the endoscope, during the exploration of the tracheobronchial tree), and the degree of acceptance to repeat the examination in the future. Each item is measured using a Likert scale of 5 points.
- Effective calculation. We evaluated two strategies for sedation during a preliminary study of 45 patients (Gaillard, SRLF 2010 summary 003940). Cough of more than 10 seconds occurred in 76% of patients sedated with propofol and 32% of patients sedated with Remifentanil. From these data, A number of N = 71 patients will have a power of 80% to demonstrate a difference by Fisher exact probability test between two groups of 35% of percentage of cough of more than 10 secondes.
- Statistical analysis. The primary endpoint and secondary endpoints will be analyzed by qualitative test of Mantel-Haentzel. The homogeneity of odds ratios (existence of a significant level of anxiety) will be tested by the Breslow-Day.Comparing the duration of each examination, the dose of lidocaine instilled, satisfaction scores and the number of increments and decrements in both groups will be made by Mann-Whitney test. For these variables, the possible interactions between the type of action and treatment are analyzed in a ANOVA model.
The duration of recruitment is 45 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2: Propofol | Active comparator | Drug: 2: PropofolControl arm: the use of TCI of hypnotic (Propofol) during realization bronchial fibroscopy. |
| 1: Remifentanil | Experimental | Drug: 1: RemifentanilInterventional arm: the use of TCI of morphinomimetic (Remifentanil) during realization bronchial fibroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient major with consent
- Patient with an indication of bronchoscopy under intravenous sedation:
Key exclusion criteria (10 listed)
- Patients with a known allergy to Remifentanil
- Patients with a known allergy to Propofol, soy, peanuts
- Pregnant women or nursing
- Neurological pathology causing intracranial hypertension
- Patients with a Body Mass Index greater than 30
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 |
|---|---|---|
| 1: Remifentanil1: Remifentanil group The infusion of Remifentanil by TCI begins at distance from the introduction of fiberoptic. The effect site target is 4 ng / ml.- A titration in increments or decrements (respectively increase or decrease of 1 ng / ml effect site concentration) separated by 1 minute intervals until an OAAS score of 4 and respiratory frequency range between 10 and 20 cycles per minute. | Drug | 1: Remifentanil |
| 2: Propofol2: Propofol group- The infusion of Propofol by TCI begins at distance from the introduction of fiberoptic. The effect site target is 2,5 ng / ml.- A titration in increments or decrements (respectively increase or decrease of 0.5 mg / ml concentration effect site) separated by 1 minute intervals until an OAAS score of 4 and included respiratory rate between 10 and 20 cycles per minute. | Drug | 2: Propofol |
Primary outcome
Duration of patient's caught
Time frame: at day0
Comparison of the duration of patient's caught during realisation of bronchial fibroscopy according to type of performed sedation (remifentanil versus propofol
5 secondary outcomes
Respiratory frequence and Gaz volume
Time frame: Day0
Fibroscopist's satisfaction
Time frame: Day0
Patient's satisfaction
Time frame: Day0
Pharmacodynamics
Time frame: Day0
Number of episodes of cough
Time frame: Day0
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 10 May 2017.
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.
Véronique J MAUREL, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1: Remifentanil and 2: Propofol in people with Realisation of Bronchial Fibroscopy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 10 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 10 May 2017. 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 France. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Duration of patient's caught (time frame: at day0). 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 10 May 2017.