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

NCT03322150 | Terminated

• 1 other identifier: 4-2013-0763
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Keywords

Atropine; glycopyrrolate; bradycardia; dexmedetomidine; spinal anesthesia

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (2)

Atropine group

ACTIVE COMPARATOR

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

Drug: Atropine

Glycopyrrolate group

ACTIVE COMPARATOR

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

Drug: Glycopyrrolate

Interventions

Atropine DRUG

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

Atropine group

Glycopyrrolate DRUG

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

Glycopyrrolate group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Bradycardia

Interventions

Atropine; Glycopyrrolate

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Quaternary Ammonium Compounds; Amines; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: October 26, 2017
• Study Start: October 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)