A monocentric prospective randomized controlled trial on the effect of crystalloids and colloids on the cardiac stroke volume during neurosurgical spine surgery

Phase 4

• Conditions: M43.9; Deforming dorsopathy, unspecified

• Registration Number: DRKS00022917
• Lead Sponsor: Justus-Liebig-Universität GießenKlinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-04
• Study Completion: 2022-01-11
• Results First Posted: 2022-12-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

informed consent
male and female patients undergoing neurosurgical spine surgery in prone position (XLIF, TLIF, spondylodesis)
Age > 18y
ASA I - III
general anaesthesia
invasive blood pressure monitoring

Exclusion Criteria

age < 18y
emergency surgery
ASA IV - V
acute heart failure
chronic heart failure NYHA III-IV
arterial fibrillation
arterial disease (> stage IIb)
chronic kidney disease (> stage II according to KDIGO)
pregnancy
lack of consent
participation in another (interventional) study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the change in cardiac stroke volume before and after intervention measured by non-calibrated hemodynamic monitoring

Secondary Outcome Measures

Name	Time	Method
change in cardiac stroke volume > 10%, requirements for catecholamines (norepinephrine, epinephrine before and after the intervention µg/kg/min), change in mean arterial pressure (MAP), perioperative fluid balance, duration and AUC of hypotension (MAP < 65 mmHg)