RecruitingNot ApplicableNCT07571473

CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy

CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy: A Randomized Controlled Trial

Sponsor

Hospital Provincial de Rosario

Enrollment

30 participants

Start Date

Jan 8, 2025

Study Type

INTERVENTIONAL

Conditions

surgical stress response Anesthesia Inflammation Perioperative Care

Summary

This randomized controlled trial evaluates whether intraoperative guidance using the CoreSys monitor reduces the surgical stress response in patients undergoing elective open abdominal hysterectomy. Surgical stress involves complex hemodynamic, endocrine, and inflammatory responses that may negatively impact postoperative recovery. Patients will be randomized to either anesthesia guided by conventional clinical and hemodynamic parameters or anesthesia additionally guided by CoreSys-derived indices of consciousness, nociception, and stress activity. The primary objective is to assess whether CoreSys-guided anesthesia attenuates stress biomarkers, including interleukin-6 (IL-6), cortisol and glycemia.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called CoreSys Monitor, a drug called Remifentanil (Target-Controlled Infusion), and others for people with anesthesia, inflammation, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpropofol

Intravenous administration of propofol using target-controlled infusion (TCI) based on the Marsh pharmacokinetic model for induction and maintenance of general anesthesia.

DEVICECoreSys Monitor

A non-invasive monitoring device that integrates electroencephalographic and autonomic signals to assess hypnotic level, nociception, and intraoperative stress indices.

DRUGRemifentanil (Target-Controlled Infusion)

Intravenous administration of remifentanil using target-controlled infusion (TCI) based on the Minto pharmacokinetic model for intraoperative analgesia.