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

Not Applicable

Completed

• Conditions: Spinal Anesthesia
• Interventions: Drug: Atropine; Drug: Glycopyrrolate

• Registration Number: NCT03322098
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-16
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-26
• Primary Completion: 2018-05-15
• Study Completion: 2018-05-15
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atropine group	Atropine	Patients that receive atropine 0.01 mg/kg (max 0.5mg) before spinal anesthesia
Glycopyrrolate group	Glycopyrrolate	Patients that receive glycopyrrolate 0.004mg/kg (max 0.2 mg) before spinal anesthesia

Primary Outcome Measures

Name	Time	Method
Pulse rate	From 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 pressure	From 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.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of