Hemodynamic Monitoring, Perioperative Care, Outcome Assessment
Conditions
Keywords
Hemodynamic Monitoring, Perioperative Care, Outcome Assessment
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.
Interventions
DEVICEStandard group
Use radial arterial line to monitor mean arterial pressure
DEVICEClearSight
Use Edwards EV1000 Clinical Platform NI with ClearSight finger sleeve to monitor SV(stroke volume)
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Creatinine | preanesthesia and 24 hours postanesthesia | Creatinine (serum) |
| Urine output | after induction until recovery from anesthesia, assessed up to 24 hours | urine output ml/kg/h |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea and vomiting | postoperative 24 hours | Postoperative nausea and vomiting |
| Recovery time | From the stop of propofol infusion until full orientation of patient, up to 2 hours | 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. |
| Postoperative adverse events | postoperative 30 days | Including ileus, infection, and cardiovascular events |
| Fluid responsiveness | after induction until recovery from anesthesia, assessed up to 24 hours | After fluid challenge, MAP changes in Standard group or SV changes in ClearSight group |
Contacts
Primary ContactMin-Hsien Chiang, M.D.
Backup ContactJohnson Chia-Shen Yang, M.D.
Outcome results
None listed