Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Adult Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia

NCT ID: NCT03322150

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-08-01

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.

Conditions

Spinal Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Atropine group

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

Group Type: ACTIVE_COMPARATOR

Atropine

Intervention Type: DRUG

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

Glycopyrrolate group

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

Group Type: ACTIVE_COMPARATOR

Glycopyrrolate

Intervention Type: DRUG

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

Interventions

Atropine

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

Intervention Type: DRUG

Glycopyrrolate

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2013-0763

Identifier Type: -

Identifier Source: org_study_id