Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine Infusion
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 ↗
Publications
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 14 mg | Intrathecal |
| Comparator | Fentanyl | Other / unclassified | 20 ug | Intrathecal |
Indications
No indication recorded.