Dexmedetomidine-ketamine in Femur Proximal Fracture Patients

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Dexmedetomidine; Drug: Ketamine; Drug: Fentanyl

• Registration Number: NCT02150759
• Lead Sponsor: Inje University

Brief Summary

* Comparison study of analgesic effects for dexmedetomidine-fentanyl vs dexmedetomidine-ketamine

* 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

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-23
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-30
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Results First Submitted: 2018-08-19
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-25
• Last Update Submitted: 2019-04-25
• Results First Posted: 2019-04-29
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• American society of anesthesiologists classification 1-3 patients
• >20 years old

Exclusion Criteria

• patients refuse
• dementia patients, cooperation difficult patients
• anaphylaxis of dexmedetomidine, ketamine, local anesthetics
• heart problem (bradycardia, atrioventricular block)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine-ketamine	Ketamine	Dexmedetomidine-ketamine group
Dexmedetomidine-ketamine	Dexmedetomidine	Dexmedetomidine-ketamine group
Dexmedetomidine-fentanyl	Dexmedetomidine	Dexmedetomidine-fentanyl group
Dexmedetomidine-fentanyl	Fentanyl	Dexmedetomidine-fentanyl group

Primary Outcome Measures

Name	Time	Method
Pain Score Using Five Scales	average 10-20 minutes	We want to compare pain score (five scales; 0=calm, 1=facial grimacing, 2=moaning, 3=screaming, 4=restlessness or agitation, unable to proceed) when patients are lateral position during spinal anesthesia.

Secondary Outcome Measures

Name	Time	Method
Quality of Patient Positioning	average 10-20 minutes during spinal anesthesia	We estimate quality of patient positioning (0=not satisfactory, 1=satisfactory, 2=good, 3=optimal) during spinal anesthesia between two groups.

Trial Locations

Locations (1)

Haeundae paik hospital, inje university; 🇰🇷 Busan, Korea, Republic of