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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT03322098

Collaborator

(none)

Enrollment

Location

Arms

6.9

Actual Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Anesthesia	Drug: Atropine Drug: Glycopyrrolate	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 16, 2017

Actual Primary Completion Date :

May 15, 2018

Actual Study Completion Date :

May 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Atropine group Patients that receive atropine 0.01 mg/kg (max 0.5mg) before spinal anesthesia	Drug: Atropine Atropine injection (0.01 mg/kg, max 0.5 mg) within 3 minutes before spinal anesthesia
Active Comparator: Glycopyrrolate group Patients that receive glycopyrrolate 0.004mg/kg (max 0.2 mg) before spinal anesthesia	Drug: Glycopyrrolate Glycopyrrolate (0.00 4mg/kg, max 0.2 mg) within 3 minutes before spinal anesthesia

Arm

Intervention/Treatment

Active Comparator: Atropine group

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

Drug: Atropine

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

Active Comparator: Glycopyrrolate group

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

Drug: Glycopyrrolate

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Patients with coagulation abnormalities
End organ diseases of liver, lung or kidney
Severe aortic stenosis
High degree AV block
Heart failure
Patients on MAO inhibitors
History of seizures or epilepsy
Glaucoma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul		Korea, Republic of	03722