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

Spinal Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03322150
• Other study ID #: 4-2013-0763
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Spinal Anesthesia

Intervention

Drug:
• Atropine
Atropine injection (0.01 mg/kg, max 0.5 mg) 3 minutes before spinal anesthesia
• Glycopyrrolate
Glycopyrrolate (0.00 4mg/kg, max 0.2 mg) 3 minutes before spinal anesthesia

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse rate	measured as beats per minute, heart rate below 60 bpm or decrease of more than 30% from baseline is defined as bradycardia.	From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)
Primary	blood pressure	measured as mmHg, mean blood pressure lower than 60 mmHg or decrease of more than 30% from baseline is defined as hypotension.	From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)