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

Completed

• Conditions: Intraoperative Hypotension; Pulmonary Complication; Cardiovascular Complication

• Registration Number: NCT04025086
• Lead Sponsor: University of Catania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-29
• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-18
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency rate of early post-operative complications	7 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gaspare Rodolico Presidium - University Hospital Policlinico-Vittorio Emanuele; 🇮🇹 Catania, Sicilia, Italy