Clinical trial NCT03105115: Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine Infusion
Official title: Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Spinal
Keywords: fentanyl
dexmedetomidine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Two segment sensory block regression time
timeFrame: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours
Secondary outcomes:
measure: motor block
timeFrame: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours
measure: postoperative pain score
timeFrame: at op day, at postoperative 1st day, at postoperative 2nd day
measure: postoperative nausea and vomiting
timeFrame: at op day, at postoperative 1st day, at postoperative 2nd day
measure: intraoperative incidence of hypotension
timeFrame: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-tae Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.