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Clinical Trials/NCT05481047
NCT05481047
Completed
Not Applicable

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country48 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
HPI
Conditions
Hypotension During Surgery
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
48
Locations
1
Primary Endpoint
Cerebral tissue oximetry
Status
Completed
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
March 22, 2024
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

RUSSO ANDREA

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility Criteria

Inclusion Criteria

  • patients scheduled for abominal surgery

Exclusion Criteria

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

Arms & Interventions

prevention

investigator will prevent intraoperative arterial hypotension based on HPI index

Intervention: HPI

treatment

investigators will treat intraoperative arterial hypotension based on standard hemodynamic parameters

Outcomes

Primary Outcomes

Cerebral tissue oximetry

Time Frame: 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)

Study Sites (1)

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