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

Arterial Hypotension and Regional Cerebral Oxygen Saturation During Major Abdominal Surgery. A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability; Hypotension During Surgery
• Intervention / Treatment: Device: HPI

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00148
      • Fondazione Policlinico Universitairo Agostino Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prevention; investigator will prevent intraoperative arterial hypotension based on HPI index	Device: HPI; based on HPI values, clinicians will administer drugs or fluids in order to avoid arterial hypotension
No Intervention: treatment; investigators will treat intraoperative arterial hypotension based on standard hemodynamic parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral tissue oximetry	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)	immediately after surgery

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Andrea Russo, MD, Fondazione Policlinico Universitario Agostino Gemelli

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): March 22, 2024

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 5079 (Study Team)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No