NCT03105115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 25, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2017

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

March 30, 2017

Last Update Submit

August 27, 2018

Conditions

Anesthesia, Spinal

Keywords

fentanyldexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • motor block

    From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours

  • postoperative pain score

    at op day, at postoperative 1st day, at postoperative 2nd day

  • postoperative nausea and vomiting

    at op day, at postoperative 1st day, at postoperative 2nd day

  • intraoperative incidence of hypotension

    From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours

Study Arms (2)

intrathecal fentanyl

ACTIVE COMPARATOR

heavy bupivacaine 14mg and fentanyl 20mcg will be injected intrathecally during spinal anesthesia

Drug: fentanyl

bupivacaine only

EXPERIMENTAL

heavy bupivacaine 14mg will be injected intrathecally during spinal anesthesia

Drug: bupivacaine only

Interventions

fentanylDRUG

intrathecal fentanyl will be added as adjuvant for spinal anesthesia using heavy bupivacaine, while dexmedetomidine will be infused intravenously during operation

Also known as: Hana Pharmacy
intrathecal fentanyl
bupivacaine onlyDRUG

heavy bupivacaine will be injected intrathecally during spinal anesthesia, without fentanyl, while dexmedetomidine will be infused intravenously during operation

Also known as: AstraZeneca
bupivacaine only

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing total knee replacement arthroplasty under spinal anesthesia

You may not qualify if:

  • Contraindication of spinal anesthesia
  • inability to communicate
  • morbid obesity (BMI \> 30kg/m2)
  • spine abnormality
  • severe cardiac dysfunction
  • Height \<155cm, or \> 180cm
  • contraindication to fentanyl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 26417123BACKGROUND

  • 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.

    PMID: 26702205BACKGROUND

  • 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.

    PMID: 30679336DERIVED

MeSH Terms

Interventions

FentanylChAdOx1 nCoV-19

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsVaccines, DNANucleic Acid-Based VaccinesVaccines, SyntheticVaccinesBiological ProductsComplex MixturesCOVID-19 VaccinesViral Vaccines

Study Officials

  • Jin-tae Kim

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 7, 2017

Study Start

May 25, 2017

Primary Completion

October 24, 2017

Study Completion

October 26, 2017

Last Updated

August 29, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)