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

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Completed

Conditions

Hemodynamic Instability
Hypotension During Surgery

Treatments

Device: HPI

Study type

Interventional

Funder types

Other

Identifiers

NCT05481047
5079 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

prevention
Experimental group
Description:
investigator will prevent intraoperative arterial hypotension based on HPI index
Treatment:
Device: HPI
treatment
No Intervention group
Description:
investigators will treat intraoperative arterial hypotension based on standard hemodynamic parameters

Trial contacts and locations

1

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Central trial contact

Andrea Russo, MD

Data sourced from clinicaltrials.gov

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