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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330808
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Young-Kug Kim, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Free Tissue Flaps Other: Epidural anesthesia Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official 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
Actual Study Start Date : October 28, 2017
Actual Primary Completion Date : April 5, 2020
Actual Study Completion Date : May 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Epidural with general anesthesia
Epidural anesthesia with 0.2% ropivacaine 10 ml
Other: Epidural anesthesia
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 Name: Epidural anesthesia with ropivacaine

No Intervention: General anesthesia alone
Sevoflurane and nitrous oxide.



Primary Outcome Measures :
  1. Maximal blood flow velocity [ Time Frame: 30 minutes after flap arterial anastomosis ]
    Maximal blood flow velocity measured by using Duplex ultrasound


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330808


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Young-Kug Kim, MD, PhD Asan Medical Center
Publications:
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Responsible Party: Young-Kug Kim, Principal Investigator, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03330808    
Other Study ID Numbers: 2017-1200
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anesthetics
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents