General anesthesia, sleep, and coma.
Emery N Brown, Ralph Lydic, Nicholas D Schiff
https://pubmed.ncbi.nlm.nih.gov/21190458Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
FEMALE
ID07571473
CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy: A Randomized Controlled Trial
Led by Hospital Provincial de Rosario · Updated on 2026-05-06
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hospital Provincial de Rosario
Lead Sponsor
C
Coresys Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether using the CoreSys monitor during anesthesia can reduce the surgical stress response in women undergoing elective open abdominal hysterectomy. Surgical stress includes complex changes in the body's hormones, immune system, and heart function that may affect recovery after surgery. This randomized controlled trial compares anesthesia guided by standard clinical and hemodynamic parameters with anesthesia guided by additional CoreSys-derived indices of brain activity, pain response, and stress levels. Participants will be randomly assigned to one of two groups. One group will receive total intravenous anesthesia guided by standard monitoring plus CoreSys monitoring, which uses brain and heart signals to adjust anesthesia. The other group will receive standard anesthesia guided only by conventional clinical parameters, with CoreSys monitoring performed but not shown to the anesthesiologist. Anesthesia drugs used include propofol and remifentanil administered through target-controlled infusion. The study measures stress biomarkers such as interleukin-6, cortisol, and blood glucose at different times around surgery. During the study, researchers will monitor various parameters including blood pressure, heart rate, brain activity, stress activity, and anesthetic consumption throughout the operation. Stress-related biomarkers will be measured before anesthesia, at the end of surgery, and 24 hours later. Early postoperative complications will also be tracked during the first day after surgery. The total participation includes the surgical procedure and follow-up assessments up to 24 hours postoperatively.
CONDITIONS
Brief Title
CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy
Who Can Participate
Age: 18Years - 70Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- Scheduled for elective open abdominal hysterectomy in the morning
- Provided written informed consent
You will not qualify if you...
- Refusal to participate
- Significant endocrine or metabolic disease
- Presence of pacemaker or major heart rhythm problems
- Contraindication to epidural anesthesia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Surgical day
Participants undergo elective open abdominal hysterectomy with total intravenous anesthesia guided by standard clinical parameters, with or without additional CoreSys monitoring to manage anesthesia and intraoperative stress.
1 surgical and anesthesia visit (in-person)
Follow-up
Duration - 24 hours postoperatively
Participants are monitored for early postoperative outcomes including stress biomarkers and any complications during the first 24 hours after surgery.
1 post-operative visit (in-person)
Trial Site Locations
Total: 1 location
1
Hospital Provincial de Rosario
Rosario, Santa Fe Province, Argentina, S2001SBL
Actively Recruiting
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Research Team
M
Mariana I Ciancio, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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A Abad-Gurumeta, J Ripollés-Melchor, R Casans-Francés...
https://pubmed.ncbi.nlm.nih.gov/28341079Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures.
Patrick L Purdon, Aaron Sampson, Kara J Pavone...
https://pubmed.ncbi.nlm.nih.gov/26275092European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium.
César Aldecoa, Gabriella Bettelli, Federico Bilotta...
https://pubmed.ncbi.nlm.nih.gov/28187050Anaesthesia, analgesia, and the surgical stress response.
B Cusack, D J Buggy
https://pubmed.ncbi.nlm.nih.gov/33456967The stress response to trauma and surgery.
J P Desborough
https://pubmed.ncbi.nlm.nih.gov/10927999