Prevention or Treatment of Arterial Hypotension and Oxygen Cerebral Saturation During Major Abdominal Surgery

Not Applicable

Completed

• Conditions: Hypotension During Surgery; Hemodynamic Instability

• Registration Number: NCT05481047
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

In this study investigators will explore the association between intraoperative arterial hypotension and cerebral oxygen saturation in patients scheduled for major abdominal surgery. Investigators will assign patients to control or interventional group. In this last group arterial hypotension will be avoided based on a HPI (Hypotension Predictive Index) protocol. In the control group arterial hypotension will be promptly treated according to hemodynamic variables.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Study Start: 2022-09-01
• Primary Completion: 2023-04-01
• Status Verified: 2024-03
• Study Completion: 2024-03-22
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• patients scheduled for abominal surgery

Exclusion Criteria

• Emergency surgery
• end-stage renal disease
• pregnancy
• obesity
• atrial fibrillation
• previous cerebral ischaemia
• central nervous system disorders
• severe cardiac valvular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cerebral tissue oximetry	immediately after surgery	the difference among the two groups of the percentage value of the median value of Cerebral Oxygen Saturation measured by the near-nfrared spectroscopic technology (Foresight sensor)

Trial Locations

Locations (1)

Fondazione Policlinico Universitairo Agostino Gemelli; 🇮🇹 Roma, RM, Italy