Scoliosis Clinical Trial
Official title:
Blood and Fluid Management During Scoliosis Surgery: A Single Center Retrospective Analysis
In the present retrospective study, it was hypothesized that application, in scoliosis surgery, of a protocol for blood and fluid management, based on goal directed fluid therapy, cell salvage and tranexamic acid, could lead to reduced allogeneic red blood cells transfusion. The patients will be enrolled in a retrospective observational study and divided in two groups. Patients in no protocol Group received a liberal intraoperative fluid therapy and patients in protocol Group received fluid therapy managed according to a stroke volume variation based protocol. The protocol included fluid therapy according to SVV monitor, permissive hypotension, tranexamic acid infusion, restrictive RBC trigger and use of perioperative cell savage.
At investigators institution, neither anesthetic approaches to replacement of blood or fluid
losses were standardized before 2014 for scoliosis surgery. Before 2014, fluid therapy was
liberal and according to general principles of good clinical practice and ephedrine boluses
of 5 mg were given when fluid boluses failed to maintain a systolic arterial pressure >90 mm
Hg. Blood was replaced with crystalloid at a 3:1 ratio and colloid at a 1:1 ratio. Regarding
blood product transfusion anesthesiologists were generally initiated when hemoglobin levels
were less than 8 g/dl or less than 10 g/dl in patients with coronary diseases and predonated
autologous or allogeneic RBCs were administered.
A protocol of management for scoliosis surgery was implemented in 2014 and included: a) fluid
therapy according to SVV monitor, b) intraoperative permissive hypotension to reduce active
bleeding (goal mean arterial pressure 60 mmHg), c) prophylactic tranexamic acid infusion (30
mg/kg bolus, 1mg/kg/hr during surgery), d) restrictive RBC trigger according to national
standardized protocols (Hb<7.0 g/dL or <9g/dL in patients with coronary diseases) and e) use
of perioperative cell savage.
In patients of Group Pro, basal crystalloid infusion was started at 4 ml/kg/h right after
general anesthesia induction and intubation. ClearSight System (Edwards Lifesciences Cop,
Irvine, CA, USA) was used to measure stroke volume variation and cardiac output, continuously
and noninvasively through finger- cuffed technology. If SVV was >15% rapid crystalloid bolus
of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%. After
two consecutive fluid boluses SVV remained >15%, administration of noradrenaline infusion was
considered.
Data will be collected from anesthesia records and included: age, gender, height, weight,
body mass index and ASA score. Additional variables included infused crystalloid volume,
infused colloid volume and the number of allogeneic transfused units of RBC. Serum Hb levels
were measured preoperatively and after the end of surgery. Moreover, diuresis and use of
vasopressors use were recorded.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Recruiting |
NCT05944393 -
Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
|
N/A | |
Recruiting |
NCT05888038 -
Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair
|
N/A | |
Completed |
NCT02413788 -
Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis
|
N/A | |
Completed |
NCT02890654 -
Scoliosis and Quality of Life of Adolescents
|
||
Completed |
NCT02531945 -
Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years
|
N/A | |
Completed |
NCT02558985 -
Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application
|
||
Terminated |
NCT02134704 -
MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
|
N/A | |
Completed |
NCT02609009 -
Back Pain and Spinal Manipulation in Adolescent Scoliosis
|
N/A | |
Completed |
NCT02285621 -
Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis
|
N/A | |
Withdrawn |
NCT00768313 -
Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis.
|
Phase 4 | |
Completed |
NCT00155545 -
Influence of Leg Length Discrepancy on the Spinal Shape and Biomechanics in Functional and Idiopathic Scoliosis Patients
|
Phase 1 | |
Completed |
NCT00154505 -
Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
|
Phase 1 | |
Completed |
NCT00320619 -
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
|
N/A | |
Completed |
NCT00273598 -
Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis
|
Phase 2 | |
Completed |
NCT03135665 -
Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure
|
N/A | |
Completed |
NCT06428864 -
Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
|
||
Recruiting |
NCT04423146 -
Anesthesiologic Management Effect on Perioperative Outcome in Scoliosis Surgery
|
||
Withdrawn |
NCT02058238 -
ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
|
||
Completed |
NCT02904421 -
6 Years Study on Changes in Bone Quality, Bone Turnover and Curve Severity in AIS With and Without Calcium and Vit-D Supplementation
|