GDFT Based on PPV Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: RCT

Study Overview
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Brief Summary
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The investigators will do the Goal directed fluid therapy by protocolized fluid management in the experimental group, using PPV to guide the fluid administration, compare with standard fluid management in patients undergoing complex spine surgery.

Official Title
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Goal Directed Fluid Therapy Based on Pulse Pressure Variation Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: a Randomized Controlled Trial

Conditions
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Spine Disease

Intervention / Treatment
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* Procedure: goal directed fluid therapy
* Other: Controlled


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1-3 elective surgery thoracic/lumbar spine surgery >= 3 levels and duration >= 3 hours Exclusion Criteria: Cr >2 mg/dl or eGFR < 60 ml/min coronary artery disease, congestive heart failure or cardiac arrhythmia BMI >30 kg/m2 hemodynamic unstable, preoperatively uncontrolled hypertension respiratory system compliance < 30 ml/cmH2O

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GDFT group<br>The GDFT group will receive 400 ml of 12.5% carbohydrate drink after 6 pm until the bed time in the day before surgery and 200 ml in the morning of the surgery day. Acetate ringer solution will be start at 7:00. After induction PPV will be measure and fluid bolus 200 ml in 10 minutes will be given if PPV >13 before prone position. During the operation, the patient in GDFT group will receipt fluid therapy according to acceptable PPV | Procedure: goal directed fluid therapy<br>* pulse pressure variation will be used to as a goal to guide fluid administration in this group<br>|
| Other: controlled group<br>The carbohydrate drink will not be given. Fluid, blood and blood product administration will be under attending anesthesiologist order. | Other: Controlled<br>* standard fluid treatment by an anesthesiologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| episode of intraoperative hypotension | Blood pressure will be record continuously using arterial catheter in both group. Number of participants and episode of hypotension (defined as SBP < 90 mmHg or MAP < 60 mmHg or decrease of SPB >= 25% from baseline for 5 minutes or need vasopressor) therapy | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| unit of blood transfusion | all unit of blood transfusion will be record intraoperative and postoperative | intraoperative and up to 24 hours postoperatively |