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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

Tracking Information
First Submitted Date  ICMJE October 23, 2013
First Posted Date  ICMJE December 4, 2013
Last Update Posted Date December 4, 2013
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
  • 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.
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
  • 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
  • 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
  • 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)
  • 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.
  • Total propofol dosage [ Time Frame: Average expected time of 30 minutes ]
    The total amount of propofol used throughout the procedure will be calculated.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Propofol/Alfentanil With Propofol/Ketamine
Official Title  ICMJE Safety and Efficacy of Sedation for Flexible Fiberoptic Bronchoscopy: Comparison of Propofol/Alfentanil With Propofol/Ketamine
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.
Detailed Description

The study group will include 80 patients undergoing flexible fiberoptic bronchoscopy(FFB).

Patients will be randomly assigned prior to the procedure to receive sedation by either propofol/alfentanil (PA group) or propofol/ketamine (PK group), using either the sealed envelope method or by computer randomization.

All patients will receive local anesthesia with Lidocaine 2% (total dose of 5-10 ml) that will be sprayed via the bronchoscope on the vocal cords before passage through them, as well as into the bronchial tree in order to suppress coughing.

In addition, patients from both groups will optionally receive intravenous Midazolam (up to a total dose of 0.05 mg/kg)if deemed necessary during the procedure.

Sedation will be started by 10-15 mcg/kg Alfentanil and 0.4 mg/kg Propofol, or by 0.2-0.3 mg/kg Ketamine and 0.4 mg/kg Propofol. It will be maintained by additional boluses of Propofol (aliquots of 10-50 mg) or by additional boluses of Propofol (aliquots of 10-50 mg) and/or Ketamine (aliquots of 5-25 mg).

All patients will receive supplemental oxygen via nasal cannula (2-4 L/min) before the beginning of the procedure.

Patients whose functional oxygen saturation (SpO2) prior to the beginning of the procedure will be lower than 92% while connected to a nasal cannula, will receive oxygen supplementation via a face mask.

If the SpO2 after initiation of sedation will fall below 90%, the patients' airways will be opened using a jaw-thrust maneuver or insertion of a nasal airway. Should the SpO2 remain low, the patient will receive oxygen supplementation via a face-mask.

If deemed necessary, additional safety measures will be taken by the anesthesiologist or by the performer of the bronchoscopy, such as administration of oxygen directly through the bronchoscope, assisted ventilation with an Ambu bag, and tracheal intubation.

The duration of bronchoscopy will be calculated from the administration of sedation until the flexible bronchoscope is removed from the tracheobronchial tree.

In all cases, patients will be monitored using continuous electrocardiography, pulse oximetry, and transcutaneous carbon dioxide (PtCO2, using a digital sensor placed on the patient's earlobe),and automated noninvasive blood pressure recordings every 5 minutes. All parameters will be recorded beginning from prior to connecting the patient to the nasal cannula before initiation of sedation, throughout the entire procedure and until 10 minutes after removal of the bronchoscope from the nasopharynx.

Immediately after the end of the procedure, the bronchoscopist will grade the quality of sedation (ease of performing the procedure) by Visual Analog Scale.

A questionnaire evaluating pain and discomfort by Visual Analog Scale will be completed by the patient when fully awake after the procedure.(~30 minutes after the end of the procedure).

Percutaneous carbon dioxide tension, blood oxygenation, heart rate, and blood pressure will be compared between the groups.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Lung Disease
Intervention  ICMJE
  • Drug: Propofol
    Other Name: Diprivan
  • Drug: Ketamine
    Other Name: Ketalar
  • Drug: Alfentanil
    Other Name: Alfenta
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Propofol
    • Drug: Alfentanil
  • 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.
    Interventions:
    • Drug: Propofol
    • Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 26, 2013)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02000206
Other Study ID Numbers  ICMJE RMC13ctl
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mordechai Kremer, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mordechai R Kramer, MD Rabin Medical Center
PRS Account Rabin Medical Center
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP