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Completed

NCT Number: NCT04025086

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

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.

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Key information

Conditions

Intraoperative Hypotension Cardiovascular Complication Pulmonary Complication

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaspare Rodolico Presidium - University Hospital Policlinico-Vittorio Emanuele

Catania, Sicily, 95123, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency rate of early post-operative complications

    Time frame: 7 days

Secondary outcomes

  1. 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

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study title

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

Acronym: PGDT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 18, 2019
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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