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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

Tracking Information
First Submitted Date  ICMJE October 30, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date May 18, 2020
Actual Study Start Date  ICMJE October 28, 2017
Actual Primary Completion Date April 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
Maximal blood flow velocity [ Time Frame: 30 minutes after flap arterial anastomosis ]
Maximal blood flow velocity measured by using Duplex ultrasound
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
  • Blood volume [ Time Frame: 30 minutes after flap arterial anastomosis ]
    Blood volume measured by using Duplex ultrasound
  • Arterial blood pressure [ Time Frame: 30 minutes after flap arterial anastomosis ]
    Arterial blood pressure measured monitors
  • Cardiac output [ Time Frame: 30 minutes after flap arterial anastomosis ]
    Cardiac output measured monitors
  • Pulse pressure variability [ Time Frame: 30 minutes after flap arterial anastomosis ]
    Pulse pressure variability measured monitors
  • Body temperature [ Time Frame: 30 minutes after flap arterial anastomosis ]
    Body temperature measured monitors
  • Arterial carbon dioxide concentration [ Time Frame: 30 minutes after flap arterial anastomosis ]
    Arterial carbon dioxide concentration measured arterial blood gas analysis
  • Free flap failure [ Time Frame: Day 7 after free flap surgery ]
    Free flap failure after surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Epidural Anesthesia on Blood Flow in Arterial Anastomosis of Free Flap
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Free Tissue Flaps
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Epidural with general anesthesia
    Epidural anesthesia with 0.2% ropivacaine 10 ml
    Intervention: Other: Epidural anesthesia
  • No Intervention: General anesthesia alone
    Sevoflurane and nitrous oxide.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2017)
52
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 5, 2020
Actual Primary Completion Date April 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03330808
Other Study ID Numbers  ICMJE 2017-1200
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Young-Kug Kim, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Young-Kug Kim, MD, PhD Asan Medical Center
PRS Account Asan Medical Center
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP