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CompletedNCT03322098Updated Sep 24, 2018

Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Geriatric Patients Undergoing Total Knee Replacement Under Spinal Anesthesia

An interventional study of Atropine and Glycopyrrolate in Spinal Anesthesia, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2018-09-24.

Sponsored by Yonsei University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Spinal Anesthesia

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Keywords

  • Atropine
  • glycopyrrolate
  • bradycardia
  • dexmedetomidine
  • spinal anesthesia
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    Atropine group

    Patients that receive atropine 0.01 mg/kg (max 0.5mg) before spinal anesthesia

    Drug: Atropine

  • Active comparator
    Glycopyrrolate group

    Patients that receive glycopyrrolate 0.004mg/kg (max 0.2 mg) before spinal anesthesia

    Drug: Glycopyrrolate

Interventions

  • DrugAtropine

    Atropine injection (0.01 mg/kg, max 0.5 mg) within 3 minutes before spinal anesthesia

  • DrugGlycopyrrolate

    Glycopyrrolate (0.00 4mg/kg, max 0.2 mg) within 3 minutes before spinal anesthesia

05

What researchers measure

Primary outcomes

  1. Pulse rate

    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)

  2. blood pressure

    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)

06

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
    Seoul, 03722, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03322098
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Oct 26, 2017
Start date
Oct 16, 2017
Primary completion
May 15, 2018
Completion
May 15, 2018
Last update
Sep 24, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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