Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Geriatric Patients Undergoing Total Knee Replacement Under Spinal Anesthesia
Primary Purpose
Spinal Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atropine
Glycopyrrolate
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Anesthesia focused on measuring Atropine, glycopyrrolate, bradycardia, dexmedetomidine, spinal anesthesia
Eligibility Criteria
Inclusion Criteria:
- Patients 65 years or older undergoing total knee replacement surgery under spinal anesthesia.
- ASA class 1-3
Exclusion Criteria:
- Patients with coagulation abnormalities
- End organ diseases of liver, lung or kidney
- Severe aortic stenosis
- High degree AV block
- Heart failure
- Patients on MAO inhibitors
- History of seizures or epilepsy
- Glaucoma
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Atropine group
Glycopyrrolate group
Arm Description
Patients that receive atropine 0.01 mg/kg (max 0.5mg) before spinal anesthesia
Patients that receive glycopyrrolate 0.004mg/kg (max 0.2 mg) before spinal anesthesia
Outcomes
Primary Outcome Measures
Pulse rate
Measured as beats per minute, heart rate below 50 bpm or decrease of more than 30% from baseline is defined as bradycardia.
blood pressure
Measured as mmHg, systolic blood pressure lower than 90 mmHg or decrease of more than 30% from baseline is defined as hypotension.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03322098
Brief Title
Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Geriatric Patients Undergoing Total Knee Replacement Under Spinal Anesthesia
Official Title
Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Geriatric Patients Undergoing Total Knee Replacement Under Spinal Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients undergoing total knee arthroplasty 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 often cause hypotension or respiratory depression, especially in elderly patients. 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 in elderly patients who often have multiple comorbidities. 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 elderly patients undergoing knee surgery with spinal anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Anesthesia
Keywords
Atropine, glycopyrrolate, bradycardia, dexmedetomidine, spinal anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atropine group
Arm Type
Active Comparator
Arm Description
Patients that receive atropine 0.01 mg/kg (max 0.5mg) before spinal anesthesia
Arm Title
Glycopyrrolate group
Arm Type
Active Comparator
Arm Description
Patients that receive glycopyrrolate 0.004mg/kg (max 0.2 mg) before spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Atropine
Intervention Description
Atropine injection (0.01 mg/kg, max 0.5 mg) within 3 minutes before spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate
Intervention Description
Glycopyrrolate (0.00 4mg/kg, max 0.2 mg) within 3 minutes before spinal anesthesia
Primary Outcome Measure Information:
Title
Pulse rate
Description
Measured as beats per minute, heart rate below 50 bpm or decrease of more than 30% from baseline is defined as bradycardia.
Time Frame
From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)
Title
blood pressure
Description
Measured as mmHg, systolic blood pressure lower than 90 mmHg or decrease of more than 30% from baseline is defined as hypotension.
Time Frame
From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 65 years or older undergoing total knee replacement surgery under spinal anesthesia.
ASA class 1-3
Exclusion Criteria:
Patients with coagulation abnormalities
End organ diseases of liver, lung or kidney
Severe aortic stenosis
High degree AV block
Heart failure
Patients on MAO inhibitors
History of seizures or epilepsy
Glaucoma
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Geriatric Patients Undergoing Total Knee Replacement Under Spinal Anesthesia
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