Clinical trial NCT03330808: Effect of Epidural Anesthesia on Blood Flow in Arterial Anastomosis of Free Flap
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Free Tissue Flaps
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Maximal blood flow velocity
timeFrame: 30 minutes after flap arterial anastomosis
Secondary outcomes:
measure: Blood volume
timeFrame: 30 minutes after flap arterial anastomosis
measure: Arterial blood pressure
timeFrame: 30 minutes after flap arterial anastomosis
measure: Cardiac output
timeFrame: 30 minutes after flap arterial anastomosis
measure: Pulse pressure variability
timeFrame: 30 minutes after flap arterial anastomosis
measure: Body temperature
timeFrame: 30 minutes after flap arterial anastomosis
measure: Arterial carbon dioxide concentration
timeFrame: 30 minutes after flap arterial anastomosis
measure: Free flap failure
timeFrame: Day 7 after free flap surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Young-Kug Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.