An interventional study of fentanyl and bupivacaine only in Anesthesia, Spinal, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-29.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
heavy bupivacaine 14mg and fentanyl 20mcg will be injected intrathecally during spinal anesthesia
Drug: fentanyl
heavy bupivacaine 14mg will be injected intrathecally during spinal anesthesia
Drug: bupivacaine only
intrathecal fentanyl will be added as adjuvant for spinal anesthesia using heavy bupivacaine, while dexmedetomidine will be infused intravenously during operation
Also known as: Hana Pharmacy
heavy bupivacaine will be injected intrathecally during spinal anesthesia, without fentanyl, while dexmedetomidine will be infused intravenously during operation
Also known as: AstraZeneca
Two segment sensory block regression time
Time from highest sensory block level to two segment regression
Time frame: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours
motor block
modified Bromage scale
Time frame: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours
postoperative pain score
VAS scale
Time frame: at op day, at postoperative 1st day, at postoperative 2nd day
postoperative nausea and vomiting
VAS scale
Time frame: at op day, at postoperative 1st day, at postoperative 2nd day
intraoperative incidence of hypotension
hypotension : SBP decreased by more than 30% of baseline SBP
Time frame: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours
Plan to share: No
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital