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Anesthetic Management Guided by the Medstrom Instrument

NCT07089017 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-27

No results posted yet for this study

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.

Conditions

  • Pain Management

Interventions

DEVICE

medstrom仪器

In addition to conventional monitoring methods, such as electrocardiography (ECG), bispectral index (BIS), and train-of-four (TOF) monitoring, Medstrom instruments were utilized to assess and monitor the patient's pain, sedation, and muscle relaxation status.

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Pei qi Wang · The Firsst Medical Center ,Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-09-01
Completion
2026-12-31

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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 NCT07089017 on ClinicalTrials.gov