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

Not Applicable

Completed

• Conditions: Free Tissue Flaps
• Interventions: Other: Epidural anesthesia

• Registration Number: NCT03330808
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-10-28
• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-06
• Primary Completion: 2020-04-05
• Status Verified: 2020-05
• Study Completion: 2020-05-05
• Last Update Submitted: 2020-05-15
• Last Update Posted: 2020-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural with general anesthesia	Epidural anesthesia	Epidural anesthesia with 0.2% ropivacaine 10 ml

Primary Outcome Measures

Name	Time	Method
Maximal blood flow velocity	30 minutes after flap arterial anastomosis	Maximal blood flow velocity measured by using Duplex ultrasound

Secondary Outcome Measures

Name	Time	Method
Free flap failure	Day 7 after free flap surgery	Free flap failure after surgery
Blood volume	30 minutes after flap arterial anastomosis	Blood volume measured by using Duplex ultrasound
Arterial blood pressure	30 minutes after flap arterial anastomosis	Arterial blood pressure measured monitors
Cardiac output	30 minutes after flap arterial anastomosis	Cardiac output measured monitors
Pulse pressure variability	30 minutes after flap arterial anastomosis	Pulse pressure variability measured monitors
Body temperature	30 minutes after flap arterial anastomosis	Body temperature measured monitors
Arterial carbon dioxide concentration	30 minutes after flap arterial anastomosis	Arterial carbon dioxide concentration measured arterial blood gas analysis

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of