Clinical trial NCT03553667: Using the "Edwards" EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis
Official title: Perioperative Hemodynamic Optimization Using the "Edwards" EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodynamic Monitoring
Perioperative Care
Outcome Assessment
Keywords: Hemodynamic Monitoring
Perioperative Care
Outcome Assessment
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximal MAP fluctuation
timeFrame: after induction until recovery from anesthesia, assessed up to 24 hours
measure: Maximal change of SVV
timeFrame: after induction until recovery from anesthesia, assessed up to 24 hours
Secondary outcomes:
measure: Urine output
timeFrame: after induction until recovery from anesthesia, assessed up to 24 hours
measure: Creatinine
timeFrame: preanesthesia and 24 hours postanesthesia
measure: Acute kidney injury
timeFrame: Loss of kidney function that develops within 7 days after surgery
measure: Total fluid volume (ml)
timeFrame: after induction until recovery from anesthesia, assessed up to 24 hours
Other outcomes:
measure: Fluid responsiveness
timeFrame: after induction until recovery from anesthesia, assessed up to 24 hours
measure: Postoperative adverse events
timeFrame: postoperative 30 days
measure: Postoperative nausea and vomiting
timeFrame: postoperative 24 hours
measure: Recovery time
timeFrame: From the stop of propofol infusion until full orientation of patient, up to 2 hours
Locations:
Study officials:
affiliation: Department of Anesthesiology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine
name: Shao-Chun Wu, M.D.
role: STUDY_CHAIR
References: