Anesthesia, Spinal
Conditions
Keywords
fentanyl, dexmedetomidine
Brief summary
Intravenous infusion of dexmedetomidine during procedure was known to be associated prolonged duration of spinal anesthesia. In patients receiving dexmedetomidine infusion during procedure, it has been not evaluated whether use of adjuvant intrathecal fentanyl had additional prolonging effect on duration of spinal anesthesia or not. Therefore, the investigators planned this trial to compare clinical outcomes in patients receiving spinal anesthesia with heavy bupivacaine only and heavy bupivacaine plus fentanyl adjuvant.
Interventions
DRUGfentanyl
intrathecal fentanyl will be added as adjuvant for spinal anesthesia using heavy bupivacaine, while dexmedetomidine will be infused intravenously during operation
DRUGbupivacaine only
heavy bupivacaine will be injected intrathecally during spinal anesthesia, without fentanyl, while dexmedetomidine will be infused intravenously during operation
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing total knee replacement arthroplasty under spinal anesthesia
Exclusion criteria
* Contraindication of spinal anesthesia * inability to communicate * morbid obesity (BMI \> 30kg/m2) * spine abnormality * severe cardiac dysfunction * Height \<155cm, or \> 180cm * contraindication to fentanyl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two segment sensory block regression time | From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours | Time from highest sensory block level to two segment regression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| motor block | From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours | modified Bromage scale |
| postoperative pain score | at op day, at postoperative 1st day, at postoperative 2nd day | VAS scale |
| postoperative nausea and vomiting | at op day, at postoperative 1st day, at postoperative 2nd day | VAS scale |
| intraoperative incidence of hypotension | From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours | hypotension : SBP decreased by more than 30% of baseline SBP |
Countries
South Korea
Outcome results
None listed