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.
Dexmedetomidine-ketamine in Femur Proximal Fracture Patients
Brief Summary
* Comparison study of analgesic effects for dexmedetomidine-fentanyl vs dexmedetomidine-ketamine
* lateral position for spinal anesthesia in femur proximal fracture patients
Intervention / Treatment
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Dexmedetomidine (DRUG)dexmedetomidine infusion during spinal anesthesia
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Fentanyl (DRUG)add dexmedetomidine during position change
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Ketamine (DRUG)add dexmedetomidine during position change
Condition or Disease
- Pain
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 20 Years and older (Adult, Older Adult) |
| Enrollment: | 46 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Other |
MaskingQUADRUPLE:
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Clinical Trial Dates
| Start date: | May 01, 2014 | |
|---|---|---|
| Primary Completion: | Nov 01, 2017 | ACTUAL |
| Completion Date: | Nov 01, 2017 | ACTUAL |
| Study First Posted: | May 30, 2014 | ESTIMATED |
| Results First Posted: | Apr 29, 2019 | ACTUAL |
| Last Updated: | Apr 25, 2019 |
Sponsors / Collaborators
Lead Sponsor:
Inje University
Responsible Party:
N/A
Location
* 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
Participant Groups
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Dexmedetomidine-ketamine group
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Dexmedetomidine-fentanyl group
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 20 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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)
* 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)
Primary Outcomes
Secondary Outcomes
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We estimate quality of patient positioning (0=not satisfactory, 1=satisfactory, 2=good, 3=optimal) during spinal anesthesia between two groups.
More Details
| NCT Number: | NCT02150759 |
|---|---|
| Other IDs: | 2014-027 |
| Study URL: | https://clinicaltrials.gov/study/NCT02150759 |
Last updated: Sep 29, 2023