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Dexmedetomidine Versus Propofol Sedation in Flexible Bronchoscopy: A Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04211298
Recruitment Status : Unknown
Verified December 2019 by Mordechai Kremer, Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : December 26, 2019
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Mordechai Kremer, Rabin Medical Center

Study Description
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Brief Summary:

The study will evaluate clinical outcomes during bronchoscopy procedures with dexmedetomidine in comparison to propofol.

The clinical outcomes that will be evaluated are: oxygen saturation, transcutaneous Pco2, blood pressure and complications


Condition or disease Intervention/treatment Phase
Sedation Complication Drug: Dexmedetomidine Drug: Propofol Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dexmedetomidine Versus Propofol Sedation in Flexible Bronchoscopy: A Randomized Controlled Trial
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dexmedetomidine
Dexmedetomidine will be used for sedation during bronchoscopy
 Drug: Dexmedetomidine
Dexmedetomidine will be used for sedation during bronchoscopy
Placebo Comparator: Propofol
Propofol will be used for sedation during bronchoscopy
 Drug: Propofol
Propofol


Outcome Measures
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Primary Outcome Measures :
  1. number of de-saturation events [ Time Frame: During the procedure ]
    Number of events during bronchoscopy when saturation level decreased under 90%

  2. Oxygen saturation time < 90% [ Time Frame: During the procedure ]
    Total time during the procedure that the oxygen saturation was under 90%


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients in the age group 18 to 70 years requiring flexible bronchoscopic evaluation of the airway in the Pulmonary institute at Rabin medical center

Exclusion Criteria:

  • known or suspected allergy to any of the study drugs, seizure disorder, renal (with serum creatinine > 2 mg/dL) or hepatic impairment (elevated liver enzymes > 2 times normal), haemodynamic instability (bradycardia with HR < 50 bpm or hypotension with SBP < 90 mmHg), or seriously ill patients with American Society of Anesthesiologists' physical status above III
Contacts and Locations
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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): NCT04211298


Contacts
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Contact: Barak Pertzov, MD 972548080196 pertzovb@gmail.com
Contact: Mordechai Kramer, MD 97239377224 Kremerm@clalit.org.il

Locations
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Israel
Rabin Medical Center Recruiting
Petach Tikva, Israel, 49100
Contact: Mordechai R Kramer, MD         
Principal Investigator: Mordechai R Kramer, MD         
Sponsors and Collaborators
Rabin Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mordechai Kremer, Head of the pulmonary division, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT04211298    
Other Study ID Numbers: 0312-19-RMC
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
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