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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard group | Active Comparator | Adult patients, Creatinine clearance >= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis |
|
| ClearSight | Experimental | Adult patients, Creatinine clearance >= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard group | Device | Use radial arterial line to monitor mean arterial pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal MAP fluctuation | In standard group, MAP(mean arterial pressure measured from arterial line), maximum minus minimum | after induction until recovery from anesthesia, assessed up to 24 hours |
| Maximal change of SVV | In ClearSight group, SVV(stroke volume variation measured from ClearSight), maximum minus minimum | after induction until recovery from anesthesia, assessed up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Urine output | urine output ml/kg/h | after induction until recovery from anesthesia, assessed up to 24 hours |
| Creatinine | Creatinine (serum) |
| Measure | Description | Time Frame |
|---|---|---|
| Fluid responsiveness | After fluid challenge, MAP changes in Standard group or SV changes in ClearSight group | after induction until recovery from anesthesia, assessed up to 24 hours |
| Postoperative adverse events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min-Hsien Chiang, M.D. | Contact | +886-7-7317123 | 2788 | b9005035@cgmh.org.tw |
| Johnson Chia-Shen Yang, M.D. | Contact | +886-7-7317123 | 2788 |
| Name | Affiliation | Role |
|---|---|---|
| Shao-Chun Wu, M.D. | Department of Anesthesiology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine | Study Chair |
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| ClearSight | Device | Use Edwards EV1000 Clinical Platform NI with ClearSight finger sleeve to monitor SV(stroke volume) |
|
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| preanesthesia and 24 hours postanesthesia |
| Acute kidney injury | use AKIN/RIFLE criteria | Loss of kidney function that develops within 7 days after surgery |
| Total fluid volume (ml) | In both groups, total crystalloid fluid volume used during anesthesia | after induction until recovery from anesthesia, assessed up to 24 hours |
Including ileus, infection, and cardiovascular events
| postoperative 30 days |
| Postoperative nausea and vomiting | Postoperative nausea and vomiting | postoperative 24 hours |
| Recovery time | From the stop of propofol infusion until full orientation of patient. Full orientation needs patients to be aware of where they are and who they are. | From the stop of propofol infusion until full orientation of patient, up to 2 hours |