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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05481047
Enrollment
48
Registered
2022-08-01
Start date
2022-09-01
Completion date
2024-03-22
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability, Hypotension During Surgery

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.

Interventions

DEVICEHPI

based on HPI values, clinicians will administer drugs or fluids in order to avoid arterial hypotension

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cerebral tissue oximetryimmediately after surgerythe 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)

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORAndrea Russo, MD

Fondazione Policlinico Universitario Agostino Gemelli

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026