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

Chang Gung Medical Foundation

Status: Unknown

Conditions: Outcome Assessment; Perioperative Care; Hemodynamic Monitoring

Treatments: Device: Standard group; Device: ClearSight

Study type: Interventional

Funder types: Other

Identifiers

NCT03553667

201701797B0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Standard group

Active Comparator group

Description:

Adult patients, Creatinine clearance \>= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis

Treatment:

Device: Standard group

ClearSight

Experimental group

Description:

Adult patients, Creatinine clearance \>= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis

Treatment:

Device: ClearSight