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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

Primary Purpose

Spinal Anesthesia

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atropine
Glycopyrrolate
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Anesthesia focused on measuring Atropine, glycopyrrolate, bradycardia, dexmedetomidine, spinal anesthesia

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

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 60 bpm or decrease of more than 30% from baseline is defined as bradycardia.
blood pressure
measured as mmHg, mean blood pressure lower than 60 mmHg or decrease of more than 30% from baseline is defined as hypotension.

Secondary Outcome Measures

Full Information

First Posted
October 23, 2017
Last Updated
March 12, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03322150
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
The research was terminated because the recruitment of the study subjects was not smooth and the overseas training of the investigator was scheduled.
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 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 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.

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
2 (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) 3 minutes before spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate
Intervention Description
Glycopyrrolate (0.00 4mg/kg, max 0.2 mg) 3 minutes before spinal anesthesia
Primary Outcome Measure Information:
Title
Pulse rate
Description
measured as beats per minute, heart rate below 60 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, mean blood pressure lower than 60 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
20 Years
Maximum Age & Unit of Time
60 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 Adult Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia

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