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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2018-05-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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) within 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) within 3 minutes before spinal anesthesia

Interventions

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Atropine

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

Intervention Type DRUG

Glycopyrrolate

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

Intervention Type DRUG

Eligibility Criteria

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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

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No