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NCT05481047 Clinical Trial

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

Hemodynamic Instability Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05481047
Other study ID # 5079
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date March 22, 2024

Study information
Verified date March 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date March 22, 2024
Est. primary completion date April 1, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy Fondazione Policlinico Universitairo Agostino Gemelli Roma RM

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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