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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intrathecal fentanyl | Active Comparator | heavy bupivacaine 14mg and fentanyl 20mcg will be injected intrathecally during spinal anesthesia |
|
| bupivacaine only | Experimental | heavy bupivacaine 14mg will be injected intrathecally during spinal anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fentanyl | Drug | intrathecal fentanyl will be added as adjuvant for spinal anesthesia using heavy bupivacaine, while dexmedetomidine will be infused intravenously during operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Two segment sensory block regression time | Time from highest sensory block level to two segment regression | From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| motor block | modified Bromage scale | From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours |
| postoperative pain score | VAS scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-tae Kim | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26417123 | Background | Seetharam KR, Bhat G. Effects of isobaric ropivacaine with or without fentanyl in subarachnoid blockade: A prospective double-blind, randomized study. Anesth Essays Res. 2015 May-Aug;9(2):173-7. doi: 10.4103/0259-1162.152149. | |
| 26702205 | Background | Singh R, Kundra S, Gupta S, Grewal A, Tewari A. Effect of clonidine and/or fentanyl in combination with intrathecal bupivacaine for lower limb surgery. J Anaesthesiol Clin Pharmacol. 2015 Oct-Dec;31(4):485-90. doi: 10.4103/0970-9185.169069. |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D000090985 | ChAdOx1 nCoV-19 |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019444 | Vaccines, DNA |
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|
| bupivacaine only | Drug | heavy bupivacaine will be injected intrathecally during spinal anesthesia, without fentanyl, while dexmedetomidine will be infused intravenously during operation |
|
|
| at op day, at postoperative 1st day, at postoperative 2nd day |
| postoperative nausea and vomiting | VAS scale | 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 | From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours |
| 30679336 | Derived | Park SK, Lee JH, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Comparison of bupivacaine plus intrathecal fentanyl and bupivacaine alone for spinal anesthesia with intravenous dexmedetomidine sedation: a randomized, double-blind, noninferiority trial. Reg Anesth Pain Med. 2019 Apr;44(4):459-465. doi: 10.1136/rapm-2018-100084. Epub 2019 Jan 23. |
| D000087504 |
| Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |