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Target-Controlled Infusion (TCI) Effectiveness in Hysteroscopy

NCT07023263 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2025-06-15

No results posted yet for this study

Summary

This prospective, randomized, observational study aims to evaluate the perioperative anesthetic efficacy of different Target-Controlled Infusion (TCI) models-specifically Minto, Schnider, and Eleveld pharmacokinetic models-in patients undergoing hysteroscopy under general anesthesia. 90 female patients will be randomized into two groups, each receiving different TCI model combinations for propofol and remifentanil. Primary outcomes include intraoperative consciousness (BIS/SEF), analgesia (ANI), tissue oxygenation (NIRS), and recovery parameters. The study seeks to identify model-specific benefits regarding patient and surgeon satisfaction, recovery time, and complication rates.

Conditions

  • Anesthesia Depth Monitoring
  • Analgesia Assessment
  • Perioperative Safety and Recovery
  • Target Controlled İnfusion

Interventions

DEVICE

Schnider+ Mİnto

Patients assigned to the Standart TCI model Group would have Schnider + Minto models throughout the surgery. The patients would be monitorized with anesthesia depth, analgesia monitoring, NIRS, and recovery parameters.

DEVICE

Eleveld

Patients assigned to the Eleveld TCI model Group would have Eleveld+Eleveld models throughout the surgery. The patients would be monitorized with anesthesia depth, analgesia monitoring, NIRS, and recovery parameters.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2025-07-30
Completion
2025-08-30
FDA Device
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT07023263 on ClinicalTrials.gov