Perioperative Goal Directed Therapy (PGDT) in Spinal Surgery in the Prone Position

Intraoperative Hypotension Clinical Trial

— PGDT  

Official title:

Perioperative Goal Directed Therapy (PGDT) in Spinal Surgery in the Prone Position: Optimization of Fluid Therapy, Haemodynamic Impact and on Post-operative Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04025086
• Other study ID #: 52/2018/PO
• Status: Completed
• Start date: October 29, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: April 2021
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims at evaluating if a specific protocol, that can be framed in the innovative concept of Perioperative Goal Directed Therapy (PGDT), based on the evaluation of the Stroke Volume Variation (SVV) - a parameter deriving from the adoption of a minimally invasive advanced hemodynamic monitoring technology with a special sensor called FloTrac® (Edwards) or of a non-invasive monitoring system with the Clearsight® sensor (Edwards) - is able to guarantee a greater precision in the intraoperative management of patients undergoing spinal surgery in prone position.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age between 18-80 years
• American Society of Anesthesiologists(ASA) Classification I-II-III
• Minor and major spinal surgery
• Prone position
• Sinus rhythm
• Absence of atrial fibrillation. or severe arrhythmia
• Informed consent

Exclusion Criteria:

• Absence of informed consent
• Age less than 18 or older than 80 years
• Cardiac rhythm abnormalities: atrial fibrillation and / or severe arrhythmia

Related Conditions & MeSH terms

• Cardiovascular Complication
• Hypotension
• Intraoperative Hypotension
• Pulmonary Complication

Locations

Country	Name	City	State
Italy	Gaspare Rodolico Presidium - University Hospital Policlinico-Vittorio Emanuele	Catania	Sicilia

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency rate of early post-operative complications		7 days
Secondary	Comparison between the two commonly adopted anesthetic techniques (totally intravenous anesthesia (TIVA / TCI) or balanced anesthesia) in terms of intraoperative management of the patient and post-operative complication		7 days