Anesthesia, Spinal Clinical Trial
Official title:
Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine
Verified date | August 2018 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | October 26, 2017 |
Est. primary completion date | October 24, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | motor block | modified Bromage scale | From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours | |
Secondary | postoperative pain score | VAS scale | at op day, at postoperative 1st day, at postoperative 2nd day | |
Secondary | postoperative nausea and vomiting | VAS scale | at op day, at postoperative 1st day, at postoperative 2nd day | |
Secondary | 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 |
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