Study Comparing the Use of Remifentanil Versus Propofol for Performing Bronchial Fibroscopy (REVPRO)
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|ClinicalTrials.gov Identifier: NCT01872754|
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Realisation of Bronchial Fibroscopy||Drug: 1: Remifentanil Drug: 2: Propofol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Randomized and Single Blind Study Comparing Remifentanil Sedation Versus Propofol for Performing Bronchial Fibroscopies Under Intravenous Anesthesia|
|Actual Study Start Date :||July 31, 2013|
|Actual Primary Completion Date :||April 3, 2017|
|Actual Study Completion Date :||April 3, 2017|
Active Comparator: 2: Propofol
Control arm: the use of TCI of hypnotic (Propofol) during realization bronchial fibroscopy.
Drug: 2: Propofol
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.
Experimental: 1: Remifentanil
Interventional arm: the use of TCI of morphinomimetic (Remifentanil) during realization bronchial fibroscopy.
Drug: 1: Remifentanil
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.
- 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
- Respiratory frequence and Gaz volume [ Time Frame: Day0 ]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.
- Fibroscopist's satisfaction [ Time Frame: Day0 ]Compare treatment modalities in terms of satisfaction for fibroscopist in 2 areas: the quality of fibroscopy and quality of sedation.
- Patient's satisfaction [ Time Frame: Day0 ]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.
- Pharmacodynamics [ Time Frame: Day0 ]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.
- Number of episodes of cough [ Time Frame: Day0 ]Compare the number of episodes of cough according to the type of sedation used
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872754
|Hôpital Saint-Louis - Anesthésie Réanimation|
|Paris, France, 75010|
|Principal Investigator:||Véronique J MAUREL, MD||Assistance Publique - Hôpitaux de Paris|