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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03105115
Other study ID # H-1612-099-815
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 25, 2017
Est. completion date October 26, 2017

Study information

Verified date August 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
fentanyl
intrathecal fentanyl will be added as adjuvant for spinal anesthesia using heavy bupivacaine, while dexmedetomidine will be infused intravenously during operation
bupivacaine only
heavy bupivacaine will be injected intrathecally during spinal anesthesia, without fentanyl, while dexmedetomidine will be infused intravenously during operation

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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

Outcome

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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