Clinical Trial

Anesthetic Management Guided by the Medstrom Instrument

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Summary
This clinical trial seeks to evaluate the feasibility of the Medstrom device for integrated real-time monitoring of pain, sedation, and neuromuscular blockade during laparoscopic radical colectomy. By addressing limitations of conventional multi-device monitoring systems-including data conflicts, interpretation delays, and elevated costs-the study examines whether Medstrom can comprehensively assess intraoperative patient status and effectively guide anesthesia management using validated reference metrics. Key questions being investigated include: 1. Whether Medstrom can concurrently generate reliable pain, sedation, and neuromuscular indices through a single platform, and if these outputs demonstrate significant correlation with gold-standard measures (HRV for pain, BIS for sedation, TOF for neuromuscular blockade); 2. Whether integrated monitoring reduces intraoperative decision latency (e.g., accelerated pain detection) and mitigates inter-device interference (e.g., BIS distortion by neuromuscular agents); 3. Whether Medstrom introduces device-related adverse events (e.g., cutaneous irritation, signal misinterpretation) while potentially reducing anesthesia complications (e.g., respiratory depression, intraoperative awareness). Researchers will randomize patients undergoing elective laparoscopic radical colectomy into two groups: 1. Group T(Medstrom -guided):an intervention group receiving continuous multimodal monitoring via Medstrom, 2. Group C (Conventional):a control group undergoing conventional monitoring (BIS + TOF + hemodynamic parameters). Synchronized data will be captured at eight predefined intraoperative timepoints for correlation analysis between Medstrom-derived indices and conventional metrics.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-25.
Trial Details
NCT Number NCT07089017
Lead Sponsor Chinese PLA General Hospital
Conditions Pain Management
Enrollment 30 participants
Start Date 2026-02-01
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-27