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CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy

NCT07571473 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Surgical Stress Response
  • Inflammation
  • Anesthesia
  • Perioperative Care

Interventions

DRUG

Remifentanil (Target-Controlled Infusion)

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

DRUG

propofol

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

DEVICE

CoreSys Monitor

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

Sponsors & Collaborators

  • Coresys Health

    collaborator INDUSTRY

  • Hospital Provincial de Rosario

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-08
Primary Completion
2026-05-30
Completion
2026-05-30

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07571473 on ClinicalTrials.gov