Body Temperature and Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery

Hypothermia; Anesthesia Clinical Trial

Official title:

The Effect of the Alterations in Body Temperature to Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04686214
• Other study ID #: 2019/145
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2020
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, patient groups in which normothermia is preserved by using multiple active warming methods in the intraoperative period in AIS surgery, followed by a single compressed air blowing system and allowed mild to moderate hypothermia were compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patients between the ages of 12-18 who were evaluated as ASI by axial skeletal deformity, who would undergo elective deformity correction surgery, who did not have scoliosis due to a secondary cause, and whose data were allowed to be used by themselves and parents

Exclusion Criteria:

• Patients with body weight <35kg, morbid obesity (BMI> 40kg / m2), known allergy, known bleeding-coagulation disease, use of drugs that affect blood clotting parameters in the last week, presence of hepatic, renal, hematological, rheumatological disease, the patient's own or family with psychiatric disorders who could not cooperate

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia; Anesthesia
• Scoliosis

Intervention

Procedure:
• heating
patients were aggressively warmed using multiple heating methods such as pressurized air heater and intravenous fluid heater

Locations

Country	Name	City	State
Turkey	Istanbul University, Faculty of Medicine	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss in the group of patients who are kept normothermic	to test that blood loss is reduced in the group of patients who are kept normothermic by applying aggressive multiple warming method compared to the patient group in which mild-moderate hypothermia was allowed by using a standard single heater in an operation that poses a high risk for bleeding and hypothermia, such as AIS deformity correction surgery.	surgery time (approximately 2 hours)