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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06439732
Other study ID # 6704
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date July 1, 2026

Study information

Verified date May 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Andrea Russo, MD
Phone 0630154507
Email russoandreamd@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study investigators will study the association between the use of an hemodynamic monitoring system and the anesthetic consumption in patients following major abdominal surgery. Investigators will randomise patients for a control group and an intervention group. Patients belonging to intervention group will be monitored with a non-invasively continue system (Acumen IQ cuff sensor), while the control group will be monitored with a non-invasive intermittent pressure system. The total amount of mL of Sevoflurane will be registered in both groups and the difference will be considered as the aim of our study


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 84
Est. completion date July 1, 2026
Est. primary completion date July 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - over 18 years of age - signature of informed medical consent Exclusion Criteria: - BMI> 30 - eGFR<30 - NYHA III-IV - severe cardiac valvular diseases - absence of informed medical consent

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Acumen IQ cuff
Use of Acumen IQ cuff for haemodynamic monitoring

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in Anesthetic consumption During surgery
Secondary number hypotensive episodes during surgery
Secondary duration hypotensive episodes during surgery
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