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

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

Study Description

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

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Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

France

Hôpital Saint-Louis - Anesthésie Réanimation

Paris, France, 75010

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Véronique J MAUREL, MD; Assistance Publique - Hôpitaux de Paris

More Information

• 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
• 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:

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