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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment Phase
Realisation of Bronchial Fibroscopy Drug: 1: Remifentanil Drug: 2: Propofol Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Number of episodes of cough [ Time Frame: Day0 ]
    Compare the number of episodes of cough according to the type of sedation used



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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"

Exclusion Criteria:

  • 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 :

    • 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

Information from the National Library of Medicine

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


Locations
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France
Hôpital Saint-Louis - Anesthésie Réanimation
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Véronique J MAUREL, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01872754     History of Changes
Other Study ID Numbers: P090803
2011-005175-17 ( Other Identifier: IDRCB )
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Bronchial fibroscopy
Remifentanil
Propofol
Sedation
Target Controlled Infusion

Additional relevant MeSH terms:
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Remifentanil
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents