Study Comparing the Use of Remifentanil Versus Propofol for Performing Bronchial Fibroscopy (REVPRO)
|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
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|