NCT03330808

Brief Summary

Comparing the changes of arterial anastomotic blood flow between general anesthesia alone and general anesthesia with epidural anesthesia in patients who undergoing free flap transposition using Duplex ultrasound.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration 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

Study Start

First participant enrolled

October 28, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2020

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

2.4 years

First QC Date

October 30, 2017

Last Update Submit

May 15, 2020

Conditions

Free Tissue Flaps

Outcome Measures

Primary Outcomes (1)

  • Maximal blood flow velocity

    Maximal blood flow velocity measured by using Duplex ultrasound

    30 minutes after flap arterial anastomosis

Secondary Outcomes (7)

  • Blood volume

    30 minutes after flap arterial anastomosis

  • Arterial blood pressure

    30 minutes after flap arterial anastomosis

  • Cardiac output

    30 minutes after flap arterial anastomosis

  • Pulse pressure variability

    30 minutes after flap arterial anastomosis

  • Body temperature

    30 minutes after flap arterial anastomosis

  • +2 more secondary outcomes

Study Arms (2)

Epidural with general anesthesia

EXPERIMENTAL

Epidural anesthesia with 0.2% ropivacaine 10 ml

Other: Epidural anesthesia

General anesthesia alone

NO INTERVENTION

Sevoflurane and nitrous oxide.

Interventions

Epidural anesthesiaOTHER

After anesthesia induction, epidural catheter is inserted into lumbar epidural in epidural with general anesthesia group. A 10 ml of 0.2% ropivacaine should be given in epidural space via a catheter when anastomosis of free flap is finished in epidural with general anesthesia group.

Also known as: Epidural anesthesia with ropivacaine
Epidural with general anesthesia

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to undergo free flap transfer under general anesthesia.
  • years of age or older, under 80 years of age
  • Those who voluntarily agreed to participate in this clinical study

You may not qualify if:

  • If the patient does not agree to participate in the study
  • ASA physical status IV or higher
  • If the patient was diagnosed with diabetes
  • If the patient was diagnosed with chronic renal failure
  • If the patient was diagnosed with peripheral vascular disease or hyperlipidemia
  • If vasopressors or inotropics was used preoperatively.
  • Contraindication of epidural anesthesia such as usage of anticoagulant or abnormalities of laboratory finding.
  • If the researcher finds it to be inappropriate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (5)

  • Wright CJ, Cousins MJ. Blood flow distribution in the human leg following epidural sympathetic blockade. Arch Surg. 1972 Aug;105(2):334-7. doi: 10.1001/archsurg.1972.04180080180030. No abstract available.

    PMID: 5044554BACKGROUND

  • Tuman KJ, McCarthy RJ, March RJ, DeLaria GA, Patel RV, Ivankovich AD. Effects of epidural anesthesia and analgesia on coagulation and outcome after major vascular surgery. Anesth Analg. 1991 Dec;73(6):696-704. doi: 10.1213/00000539-199112000-00005.

    PMID: 1952169BACKGROUND

  • Pallares LC, Deane CR, Baudouin SV, Evans TW. Strain gauge plethysmography and Doppler ultrasound in the measurement of limb blood flow. Eur J Clin Invest. 1994 Apr;24(4):279-86. doi: 10.1111/j.1365-2362.1994.tb01086.x.

    PMID: 8050457BACKGROUND

  • Lou F, Sun Z, Huang N, Hu Z, Cao A, Shen Z, Shao Z, Yu P, Miao C, Wu J. Epidural Combined with General Anesthesia versus General Anesthesia Alone in Patients Undergoing Free Flap Breast Reconstruction. Plast Reconstr Surg. 2016 Mar;137(3):502e-509e. doi: 10.1097/01.prs.0000479933.75887.82.

    PMID: 26910694BACKGROUND

  • Delis KT, Knaggs AL, Mason P, Macleod KG. Effects of epidural-and-general anesthesia combined versus general anesthesia alone on the venous hemodynamics of the lower limb. A randomized study. Thromb Haemost. 2004 Nov;92(5):1003-11. doi: 10.1160/TH04-04-0233.

    PMID: 15543327BACKGROUND

MeSH Terms

Interventions

Anesthesia, EpiduralRopivacaine

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Young-Kug Kim, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 6, 2017

Study Start

October 28, 2017

Primary Completion

April 5, 2020

Study Completion

May 5, 2020

Last Updated

May 18, 2020

Record last verified: 2020-05

Locations

KR(1)