Anesthetic Management Guided by the Medstrom Instrument

Starting soon · Not applicable

Conditions studied: Pain Management

In brief

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.

Key facts

Study ID

NCT07089017

Run by

Chinese PLA General Hospital

People needed

30

Starts

2026-02-01

Expected to finish

2026-12-31

Last updated by the study team

2026-01-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Timeframe \& Location: Patients treated at the First Medical Center of the Chinese PLA General Hospital between June 2025 and December 2026.
• Age: 18 to 65 years old. 3. Diagnosis: Pathologically confirmed colon cancer requiring laparoscopic radical resection.
• Physical Status: American Society of Anesthesiologists (ASA) Physical Status Class I-III.
• Informed Consent: Patients who voluntarily participate in the study and provide written informed consent.

You may not qualify if…

• 1. Body Mass Index (BMI): BMI ≥ 30 kg/m². 2. Organ Dysfunction: Severe concomitant cardiac, pulmonary, hepatic, or renal dysfunction.
• Neurological Conditions:
• History of autonomic nervous system disorders.
• Current use of medications affecting autonomic nervous system function.
• History of neuromuscular dysfunction. 4. Pregnancy/Lactation: Pregnant or lactating women. 5. Recent Surgery: History of secondary surgery within the preceding month. 6. Psychiatric/Cognitive Conditions:
• History of psychiatric disorders or cognitive impairment.
• History of psychotropic or narcotic drug abuse.
• Significant communication barriers.
• Withdrawal Criteria:
• Requirement for conversion to open surgery or other significant deviation from the planned laparoscopic approach due to intraoperative findings.

Full record on ClinicalTrials.gov

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