drugset / Trial / NCT03105115

Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine Infusion

NCT03105115 ↗

Completed 56 enrolled Seoul National University Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2017-05-25
Primary completion
2017-10-24
Completion
2017-10-26

Outcome

Met primary endpoint

paper The mean difference in the two-segment regression time between the 2 groups was 4.8 min (95 % CI -8.9 to 18.6), demonstrating the noninferiority of bupivacaine alone. PMID 30679336 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 14 mg Intrathecal
Comparator Fentanyl Other / unclassified 20 ug Intrathecal

Indications

No indication recorded.