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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03322098
Enrollment
54
Registered
2017-10-26
Start date
2017-10-16
Completion date
2018-05-15
Last updated
2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthesia

Keywords

Atropine, glycopyrrolate, bradycardia, dexmedetomidine, spinal anesthesia

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.

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Pulse rateFrom 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)Measured as beats per minute, heart rate below 50 bpm or decrease of more than 30% from baseline is defined as bradycardia.
blood pressureFrom 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)Measured as mmHg, systolic blood pressure lower than 90 mmHg or decrease of more than 30% from baseline is defined as hypotension.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026