Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-17 @ 4:45 PM
Study NCT ID:
NCT03322150
Status:
TERMINATED
Last Update Posted:
2019-03-14
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Yonsei University
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The research was terminated because the recruitment of the study subjects was not smooth and the overseas training of the investigator was scheduled.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: