Using the "Edwards" EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis

Not Applicable

• Conditions: Hemodynamic Monitoring; Perioperative Care; Outcome Assessment
• Interventions: Device: ClearSight; Device: Standard group

• Registration Number: NCT03553667
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Lymphatic venous anastomosis could be applied on patients suffering from limb lymphedema after surgery or radiotherapy. The particular pathophysiology leads unconventional fluid treatment strategy and changes in urine output. Hemodynamic monitors shows the benefits in perianesthetic care in fluid maintenance and decrease postanesthetic complication.

Invasive hemodynamic monitors, such as arterial line and FlowTrac, have risks of hematoma, infection, nerve injury in puncture site. In this study, photoplethysmography is applied comparing with conventional mean arterial pressure for perianesthetic hemodynamic optimization in bispectral index (BIS)-guided target-controlled infusion sedation on lymphatic venous anastomosis.

Detailed Description

After allocation, patients would be assigned to Standard group or ClearSight group. All patients will be sedative with BIS-guided Propofol/Alfentanil Target-Controlled Infusion. The BIS will be maintained between 40-70 with electromyography(EMG) \< 30%. Ce(effect site concentration) of Propofol is adjusted according to BIS score. Ce of Alfentanil is adjusted between 15-75 ng/ml. Patients have spontaneous respiration during the procedure with O2 simple mask. If the oxygen saturation by pulse oximetry(SpO2) \< 95%, prescribe chin lift first. Nasopharyngeal airways is given if chin lift can not improve the saturation. Crystalloid, usually Lactate Ringer, is infused with the rate 4ml/kg/hr. The goal of Standard group is to maintain mean arterial pressure(MAP) \> 60%. If MAP \< 60%, 3ml/kg crystalloid is challenged in 10 minutes. If MAP still less than 60% after the second fluid challenge, Ephedrine 4-8mg iv is prescribed. ClearSight group is to maintain stroke volume(SV). If SV decreases more than 10%, 3ml/kg crystalloid is challenged in 10 minutes. If MAP still less than 60% after the second fluid challenge, Ephedrine 4-8mg iv is prescribed.

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-30
• Last Update Submitted: 2018-05-30
• Study Start: 2018-06-10
• Study First Posted: 2018-06-12
• Last Update Posted: 2018-06-12
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Subject receiving lymphatic venous anastomosis operation with Bispectral-guided Propofol and Alfentanil target-controlled anesthesia
• Subject agrees to participate the study

Exclusion Criteria

• Age less than 18 years old
• Creatinine clearance < 30ml/min
• Vulnerable populations, including children, pregnant women, inmates, and persons with no capacity or with limited capacity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ClearSight	ClearSight	Adult patients, Creatinine clearance \>= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis
Standard group	Standard group	Adult patients, Creatinine clearance \>= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis

Primary Outcome Measures

Name	Time	Method
Maximal MAP fluctuation	after induction until recovery from anesthesia, assessed up to 24 hours	In standard group, MAP(mean arterial pressure measured from arterial line), maximum minus minimum
Maximal change of SVV	after induction until recovery from anesthesia, assessed up to 24 hours	In ClearSight group, SVV(stroke volume variation measured from ClearSight), maximum minus minimum

Secondary Outcome Measures

Name	Time	Method
Urine output	after induction until recovery from anesthesia, assessed up to 24 hours	urine output ml/kg/h
Creatinine	preanesthesia and 24 hours postanesthesia	Creatinine (serum)
Acute kidney injury	Loss of kidney function that develops within 7 days after surgery	use AKIN/RIFLE criteria
Total fluid volume (ml)	after induction until recovery from anesthesia, assessed up to 24 hours	In both groups, total crystalloid fluid volume used during anesthesia