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Sedation During Bronchoscopy:Dexmedetomidine vs Alfentanil

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ClinicalTrials.gov Identifier: NCT01805726
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : November 25, 2014
Sponsor:
Information provided by (Responsible Party):
Saint-Joseph University

Brief Summary:

The purpose of this study is to find the best sedation necessary for patients undergoing bronchoscopy. Patients are randomized to three different regimes of sedation during bronchoscopy were studied:

  1. - Group standard/control: local anesthesia only(C)
  2. - Group alfentanil + local anesthesia(A)
  3. - Group dexmedetomidine + local anesthesia(D) The primary endpoint is the bronchoscopy score. Secondary endpoints are: Level of sedation and tolerance bronchoscopy examination. Measured parameters on the safety of examination are: the lowest saturation, needs to supplemental oxygen, amnesia , choking sensation or chest pain and if the patient is ready or not to undertake bronchoscopy second time in his life if necessary. Endtidal CO2, Respiratory rate, Blood pressure, Heart rate, level of oxygen are collected every 5 minutes before, during and after the bronchoscopy.

Condition or disease Intervention/treatment Phase
Bronchoscopy Conscious Sedation Drug: xylocain Drug: Alfentanil Drug: Dexmedetomidine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Success of Sedation During Bronchoscopy: Comparison of the Effects of Dexmedetomidine, Alfentanil and Local Anesthesia
Study Start Date : February 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Xylocain (C)
(C): Local anesthesia
Drug: xylocain
Xylocain: (C): Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum
Other Name: Xylocain only

Active Comparator: Alfentanil Group + Xylocain (A)
Local anesthesia and Alfentanil
Drug: Alfentanil
(A) Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum (slow perfusion for 10 minutes) + alfentanil 10 mcg / kg (slow injection in 5 seconds)
Other Name: Alfentanil as morphinics short acting

Active Comparator: Dexmedetomidine Group + Xylocain (D)
Local anesthesia and dexmedetomidine
Drug: Dexmedetomidine
(D) Local anesthesia 1% 25 ml in total (bronchoscopy) + dexmedetomidine 0.5 mcg / kg (slow perfusion for 10 minutes) + 2 ml saline (slow injection for 5 seconds)
Other Name: Dexmedetomidine as awake sedation




Primary Outcome Measures :
  1. Bronchoscopy score [ Time Frame: At the end of the bronchoscopy procedure ]

    Feasibility / tolerance of bronchoscopy by the "score bronchoscopy" which includes:

    • The movement of the vocal cords (4 levels)
    • Cough (4 levels)
    • Movement members (4 levels) Scale will be between: minimum 3 and maximum 16


Secondary Outcome Measures :
  1. Level of sedation for bronchoscopy [ Time Frame: At the end of the bronchoscopy procedure ]
    • Level of sedation achieved according to the objective using: Nursing Instrument for the Communication of Sedation (NICS) (7 levels).
    • Dose of midazolam necessary complementary in each group. Dormicum to give to the judgment of the operator (if necessary) is predetermined speed (1 mg each minute) to the level of sedation (-1) "Level of sedation achieved according to the objective using: Nursing Instrument for the communication of Sedation (NICS) "


Other Outcome Measures:
  1. Tolerance of examination [ Time Frame: During, at the end and one hour after the bronchoscopy. ]

    Visual Analogic Scale from 0-10 to evaluate the tolerance of the procedure:

    • During the procedure
    • At the end of the procedure
    • After 1 hour of the end of the examination



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients admitted for diagnostic flexible bronchoscopy in the endoscopy department

Exclusion Criteria:

  • Bronchoscopy outside the endoscopy unit
  • Tracheal stenosis
  • SpO2 <90% in the open air
  • Bradycardia <55 per minute
  • Atrioventricular block
  • Heart failure known (EF <40%)
  • Alcoholism (> 5 drinks per week)

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): NCT01805726


Locations
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Lebanon
Hotel Dieu de France Hospital
Beirut, Lebanon
Sponsors and Collaborators
Saint-Joseph University
Investigators
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Principal Investigator: Moussa A Riachy, MD, FCCP Saint-Joseph University
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Responsible Party: Saint-Joseph University
ClinicalTrials.gov Identifier: NCT01805726    
Other Study ID Numbers: FM235
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014
Keywords provided by Saint-Joseph University:
bronchoscopy
sedation
pulmonary function
tolerance
xylocain
dexmedetomidine
alfentanil
Additional relevant MeSH terms:
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Dexmedetomidine
Alfentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Anesthetics, Intravenous
Anesthetics, General
Anesthetics