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Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Adult Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia

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ClinicalTrials.gov Identifier: NCT03322150
Recruitment Status : Terminated (The research was terminated because the recruitment of the study subjects was not smooth and the overseas training of the investigator was scheduled.)
First Posted : October 26, 2017
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief Summary:
Patients undergoing lower extremity surgery with spinal anesthesia are often sedated to reduce patient discomfort due to large noises during surgery and also to reduce anxiety. Most commonly used sedatives include propofol and midazolam, but these agents are known to often cause hypotension or respiratory depression. Dexmedetomidine is a selective alpha 2 adrenergic drug, which acts as a sedative and also has analgesia effects. In contrast to propofol or midazolam, dexmedetomidine rarely causes respiratory depression, and therefore is often used in critically ill patients in the ICU and also in patients undergoing simple procedures. Hemodynamically, dexmedetomidine evokes a biphasic blood pressure response with a short hypertensive phase and subsequent hypotension. Bradycardia is also observed in many patients, which may lead to more serious outcomes when progressing to sinus pause or shock. Therefore, drugs to prevent bradycardia during dexmedetomidine infusion may help patients maintain a more stable hemodynamic state. The present study aims to compare the ability of atropine and glycopyrrolate to prevent bradycardia during dexmedetomidine infusion in patients undergoing lower extremity orthopedic surgery with spinal anesthesia.

Condition or disease Intervention/treatment Phase
Spinal Anesthesia Drug: Atropine Drug: Glycopyrrolate Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Adult Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Atropine group
Patients that receive atropine 0.01 mg/kg (max 0.5mg) before spinal anesthesia
 Drug: Atropine
Atropine injection (0.01 mg/kg, max 0.5 mg) 3 minutes before spinal anesthesia
Active Comparator: Glycopyrrolate group
Patients that receive glycopyrrolate 0.004mg/kg (max 0.2 mg) before spinal anesthesia
 Drug: Glycopyrrolate
Glycopyrrolate (0.00 4mg/kg, max 0.2 mg) 3 minutes before spinal anesthesia


Outcome Measures
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Primary Outcome Measures :
  1. Pulse rate [ Time Frame: From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively) ]
    measured as beats per minute, heart rate below 60 bpm or decrease of more than 30% from baseline is defined as bradycardia.

  2. blood pressure [ Time Frame: From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively) ]
    measured as mmHg, mean blood pressure lower than 60 mmHg or decrease of more than 30% from baseline is defined as hypotension.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 65 years or older undergoing total knee replacement surgery under spinal anesthesia.
  2. ASA class 1-3

Exclusion Criteria:

  1. Patients with coagulation abnormalities
  2. End organ diseases of liver, lung or kidney
  3. Severe aortic stenosis
  4. High degree AV block
  5. Heart failure
  6. Patients on MAO inhibitors
  7. History of seizures or epilepsy
  8. Glaucoma
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): NCT03322150


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03322150    
Other Study ID Numbers: 4-2013-0763
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
Atropine
glycopyrrolate
bradycardia
dexmedetomidine
spinal anesthesia
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Atropine
Glycopyrrolate
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action