Blood and Fluid Management During Scoliosis Surgery

Completed

• Conditions: Scoliosis
• Interventions: Other: protocol

• Registration Number: NCT03814239
• Lead Sponsor: George Papanicolaou Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-10-30
• Primary Completion: 2016-11-20
• Status Verified: 2019-01
• Study Completion: 2019-01-01
• Study First Submitted: 2019-01-20
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-23
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. severe curve (Cobb Angle > 70-degree)
2. same surgeon in all procedures

Exclusion Criteria

1. Patients with coagulopathy,
2. morbid obesity
3. severe cardiopulmonary disease
4. liver dysfunction
5. renal disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
protocol	protocol	fluid therapy according to stroke volume variation (SVV) monitor, tranexamic acid administration, use of cell saver

Primary Outcome Measures

Name	Time	Method
units of red blood cells transfused	intraoperative	the overall units of red blood cells transfused during surgery. Hb\< 7 was the trigger for transfusion in protocol group and Hb\<8 for no transfusion group.

Secondary Outcome Measures

Name	Time	Method
volume of crystalloids infused	intraoperative	the overall volume of crystalloids infused during surgery. In patients of Group Pro, basal crystalloid infusion was started at 4 ml/kg/h If SVV was \>15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%.
diuresis	intraoperative	volume of urine production during surgery.
volume of colloids infused	intraoperative	the overall volume of colloid infused during surgery. In patients of Group Pro, basal crystalloid infusion was started at 4 ml/kg/h. If SVV was \>15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%.
infused vasopressors	intraoperative	The decision to use ephedrine or noradrenaline. In patients of Group Pro if after two consecutive fluid boluses SVV remained \>15%, administration of noradrenaline or ephedrine was considered.

Trial Locations

Locations (1)

George Papanikoalou Hospital; 🇬🇷 Thessaloníki, Greece