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Comparison of Propofol/Alfentanil With Propofol/Ketamine (KET-001)

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ClinicalTrials.gov Identifier: NCT02000206
Recruitment Status : Unknown
Verified November 2013 by Mordechai Kremer, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 4, 2013
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):
Mordechai Kremer, Rabin Medical Center

Brief Summary:
A prospective, randomized, patient-blinded comparison of the safety and efficacy of conscious sedation by propofol/alfentanil with propofol/ketamine in patients undergoing flexible fiberoptic bronchoscopy.

Condition or disease Intervention/treatment Phase
Lung Disease Drug: Propofol Drug: Ketamine Drug: Alfentanil Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Sedation for Flexible Fiberoptic Bronchoscopy: Comparison of Propofol/Alfentanil With Propofol/Ketamine
Study Start Date : February 2014
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: propofol + alfentanil

Patients from the Propofol / Alfentanil group will receive in addition:

  1. A loading dose of 10-15 mcg/kg Alfentanil + 0.4 mg/kg Propofol, 2 minutes prior to the beginning of the procedure.
  2. Additional boluses of Propofol (aliquots of 10-50 mg) throughout the procedure if required
Drug: Propofol
Other Name: Diprivan

Drug: Alfentanil
Other Name: Alfenta

Active Comparator: propofol + ketamine

Patients from the Propofol / Ketamine group will receive in addition:

  1. A loading dose of 0.2-0.3 mg/kg Ketamine + 0.4 mg/kg Propofol, 2 minutes prior to the beginning of the procedure.
  2. Additional boluses of Propofol (aliquots of 10-50 mg) and/or Ketamine (aliquots of 5-25 mg) throughout the procedure if required.
Drug: Propofol
Other Name: Diprivan

Drug: Ketamine
Other Name: Ketalar




Primary Outcome Measures :
  1. Percutaneous carbon dioxide tension [ Time Frame: Average expected time of 45 minutes ]
    Continuous measurements (record every 4 seconds). Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination.

  2. oxygen saturation [ Time Frame: Average expected time of 45 minutes. ]
    Continuous measurements (record every 4 seconds). Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination.

  3. heart rate [ Time Frame: Average expected time of 45 minutes ]
    Continuous measurements (record every 4 seconds). Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination.

  4. Non-invasive blood pressure [ Time Frame: Average expected time of 45 minutes ]
    Every 5 minutes. Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination


Secondary Outcome Measures :
  1. Oxygen supplementation [ Time Frame: Average expected time of 45 minutes ]

    Significant hypoxemia, defined as functional SpO2 of 90%, will be treated initially with a jaw thrust maneuver. If it lasts more than few seconds, a naso/oropharyngeal tube will be inserted or supplemental oxygen will be delivered via face mask at 10 L min-1.

    The percentage of patients who needed supplemental oxygen will be evaluated


  2. Naso/oropharyngeal tube insertion [ Time Frame: Average expected time of 45 minutes ]

    Significant hypoxemia, defined as functional SpO2 of 90%, will be treated initially with jaw support. If it lasts more than few seconds, a naso/oropharyngeal tube will be inserted or supplemental oxygen will be delivered via face mask at 10 L min-1

    The percentage of patients who needed Naso/oropharyngeal tube insertion will be evaluated


  3. A questionnaire evaluating pain and discomfort [ Time Frame: Ca. 30 minutes after the end of the procedure (average expected time of 60 minutes) ]
    A questionnaire evaluating pain and discomfort by Visual Analog Scale will be completed by the patient when awake after the procedure.(~30 minutes after the end of the procedure)

  4. A questionnaire evaluating the quality of sedation [ Time Frame: Immediately after end of procedure (average expected time of 30 minutes) ]
    A questionnaire evaluating the quality of sedation and the ease of performing the procedure by Visual Analog Scale will be completed by the bronchoscopist immediately after the procedure.

  5. Total propofol dosage [ Time Frame: Average expected time of 30 minutes ]
    The total amount of propofol used throughout the procedure will be calculated.

  6. Time to full awakening and orientation [ Time Frame: Anticipated to be in the range of 1-30 minutes after the end of the procedure ]
    Time from termination of the procedure to full awakening and orientation

  7. Time to discharge [ Time Frame: Average expected time of 60 minutes. Anticipated to be in the range of 45-120 minutes after the end of fiberoptic bronchoscopy ]
    The time from the termination of the procedure until the patient is discharged from the recovery unit will be measured.



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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:

  • American Society of Anesthesiologists grade I or II
  • patients that will be referred to the procedure for bronchoalveolar lavage and cytologic/bacteriologic sampling, endoluminal biopsies for pathologic /bacteriologic analysis, or for regaining patency (mechanically or laser-assisted) of airways that are obstructed by secretions, tumors or foreign bodies

Exclusion Criteria:

  • patient refusal or inability to provide informed consent
  • American Society of Anesthesiologists grade III or higher
  • allergy to study medications
  • patients who have an endotracheal tube or tracheostomy

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): NCT02000206


Contacts
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Contact: Yair Manevich, MD yair.manevich@gmail.com

Locations
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Israel
Pulmonary Institute, Rabin Medical Center, Beilinson Hospital
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Study Director: Mordechai R Kramer, MD Rabin Medical Center

Publications:

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Responsible Party: Mordechai Kremer, Head of Pulmonary Institute, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02000206     History of Changes
Other Study ID Numbers: RMC13ctl
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: November 2013
Keywords provided by Mordechai Kremer, Rabin Medical Center:
Ketamine
Alfentanil
Propofol
Oxygen saturation
Percutaneous carbon dioxide
Bronchoscopy
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Ketamine
Alfentanil
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics