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Completed

NCT Number: NCT03330808

Effect of Epidural Anesthesia on Blood Flow in Arterial Anastomosis of Free Flap

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.

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Key information

Conditions

Free Tissue Flaps

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 05505, South Korea

About this study

Maintaining adequate blood flow is important on the success of free flap surgery. Epidural anesthesia can influence blood flow during surgery. Therefore, investigators aim to compare the effect of epidural anesthesia combined with general anesthesia and general anesthesia alone on blood flow in arterial anastomosis site of the free flap.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Epidural anesthesia

Other

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.

Other names: Epidural anesthesia with ropivacaine

Primary outcomes

  1. Maximal blood flow velocity

    Time frame: 30 minutes after flap arterial anastomosis

    Maximal blood flow velocity measured by using Duplex ultrasound

Secondary outcomes

  1. Blood volume

    Time frame: 30 minutes after flap arterial anastomosis

    Blood volume measured by using Duplex ultrasound

  2. Arterial blood pressure

    Time frame: 30 minutes after flap arterial anastomosis

    Arterial blood pressure measured monitors

  3. Cardiac output

    Time frame: 30 minutes after flap arterial anastomosis

    Cardiac output measured monitors

  4. Pulse pressure variability

    Time frame: 30 minutes after flap arterial anastomosis

    Pulse pressure variability measured monitors

  5. Body temperature

    Time frame: 30 minutes after flap arterial anastomosis

    Body temperature measured monitors

  6. Arterial carbon dioxide concentration

    Time frame: 30 minutes after flap arterial anastomosis

    Arterial carbon dioxide concentration measured arterial blood gas analysis

  7. Free flap failure

    Time frame: Day 7 after free flap surgery

    Free flap failure after surgery

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Randomized Trials of Epidural Combined With General Anesthesia Versus General Anesthesia Alone to Evaluate the Changes of Blood Flow in Arterial Anastomosis of Free Flap Using Duplex Ultrasonography

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2017
Registry last updated
May 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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