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
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Tracking Information | ||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Lung Disease | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |