The study is going to be a single-centre prospective randomized trial. Patients will be randomly allocated to either control group (anesthetist-directed fluid therapy) or goal directed fluid therapy group, in which fluid therapy was guided by stoke volume (SV) algorithm with the use of Nexfin monitor. Primary outcome measures were the time to hospital discharge since surgery and the occurence of complications developed during the postoperative period. Secondary outcomes included the incidence of intraoperative hypotensive episodes (with MAP\<65mmHg) in both groups and the requirement of vasoactive drugs to support blood pressure
The study is going to be a single-centre prospective randomized trial in elderly patients undergoing hip fracture surgery under spinal anesthesia. Patients will be randomly allocated to either control group (anesthetist-directed fluid therapy) or goal directed fluid therapy group, in which fluid therapy was guided by stoke volume (SV) algorithm with the use of Nexfin monitor. In patients of the control group management of the hemodynamic status will be performed in the discretion of the attending anesthesiologist, with the aim of keeping mean arterial pressure (MAP) \> 65mmHg. The type and amount of delivered fluids, and vasoactive or inotropic drugs will be recorded. In Goal Directed Fluid Therapy group, fluid management will be guided by the Nexfin monitor, based on stroke volume of the patient under continuous tracking. Baseline SV will be measured after the patients will be turned to left/right position (at which they are going to stay throughout the whole procedure) and before the implementation of regional anesthesia. Fluid challenges of 250 ml will be repeated until the SV fails to increase by 10%. At this point, preload is considered optimized and SV optimum iss defined. SV trigger is defined as SV opt - 10%. After obtaining these values, the anesthetic and surgical interventions could proceed. During surgery, N/S 250ml boluses will be administered when SV is below SV trigger. Inotropic drugs will be administered (dobutamine infusion at 0.2-10mcg/kg/min) if CO is below 3.5 L/min and vasopressors (phenylephrine bolus doses of 50-100mcg) if SV and CO are within the target range but MAP is below 65mmHg. Primary outcome measures were the time to hospital discharge since surgery and the occurence of complications developed during the postoperative period. Secondary outcomes included the incidence of intraoperative hypotensive episodes (with MAP\<65mmHg) in both groups and the requirement of vasoactive drugs to support blood pressure
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Stroke volume variation fluid management
Usual care fluid management
2nd Department of Anaesthesiology, Attikon Hospital, 1 Rimini str.
Athens, Attica, Greece
RECRUITING2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Athens, Greece
RECRUITINGdays of hospitalization after surgery
days of hospitalization after the operation
Time frame: 30 days
complications
incidence of complications
Time frame: 30 days
hypotension
incidence of hypotensive episodes (MAP \< 65mmHg)
Time frame: during surgery
use of vasoactive agents
use of vasoactive agents (phenylephrine, dopamine) exact dose
Time frame: during surgery
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