Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-10 @ 12:39 AM
Study NCT ID:
NCT02150759
Status:
COMPLETED
Last Update Posted:
2019-04-29
First Post:
2014-05-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dexmedetomidine-ketamine in Femur Proximal Fracture Patients
Sponsor:
Inje University
Organization:
Study Overview
Official Title:
Comparison Study of Analgesic Effects for Dexmedetomidine-fentanyl vs Dexmedetomidine-ketamine in Femur Proximal Fracture Patients
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
* Comparison study of analgesic effects for dexmedetomidine-fentanyl vs dexmedetomidine-ketamine
* lateral position for spinal anesthesia in femur proximal fracture patients
* lateral position for spinal anesthesia in femur proximal fracture patients
Detailed Description:
* Dexmedetomidine (1mcg/kg)- fentanyl (1mcg/kg) vs dexmedetomidine (1mcg/kg) - ketamine (1mg/kg) 10 minutes loading.
* After 10 minutes of drug infusion, patients are prepared for spinal anesthesia.
* pain scale and quality of patient positioning are measured three times (lateral position, chest-knee position, intrathecal local anesthetics injection)
* When patients have severe pain during intraoperative period, fentanyl 50 mcg will be intravenously inject.
* Patients will be injected propofol 10mg when they have agitation signs during operation.
* vital signs, bispectral index, korean version of mini mental status examination, verbal rating scale,fentany/propofol consumption, frequency of intrathecal injection
* After 10 minutes of drug infusion, patients are prepared for spinal anesthesia.
* pain scale and quality of patient positioning are measured three times (lateral position, chest-knee position, intrathecal local anesthetics injection)
* When patients have severe pain during intraoperative period, fentanyl 50 mcg will be intravenously inject.
* Patients will be injected propofol 10mg when they have agitation signs during operation.
* vital signs, bispectral index, korean version of mini mental status examination, verbal rating scale,fentany/propofol consumption, frequency of intrathecal injection
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: