Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Two segment sensory block regression time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
intrathecal fentanyl
heavy bupivacaine 14mg and fentanyl 20mcg will be injected intrathecally during spinal anesthesia
Intervention: fentanyl (Drug)
bupivacaine only
heavy bupivacaine 14mg will be injected intrathecally during spinal anesthesia
Intervention: bupivacaine only (Drug)
Outcomes
Primary Outcomes
Two segment sensory block regression time
Time Frame: 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 Outcomes
- postoperative pain score(at op day, at postoperative 1st day, at postoperative 2nd day)
- motor block(From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours)
- intraoperative incidence of hypotension(From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours)
- postoperative nausea and vomiting(at op day, at postoperative 1st day, at postoperative 2nd day)
Investigators
Jin-Tae Kim
Associate professor
Seoul National University Hospital