Clinical trial · Interventional
Anesthetic Management Guided by the Medstrom Instrument
Evaluation of the Feasibility of the Medstrom Medical Device in Laparoscopic Radical Colectomy for Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain Management | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| medstrom仪器 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- No Intervention: Group C
- description
- Standard care using separate BIS (target 40-60) + TOF + standard hemodynamic monitoring.
- type
- EXPERIMENTAL
- label
- Experimental:Group T
- description
- Continuous monitoring using palmar/plantar sensors with real-time display of integrated pain, sedation, and NMB indices guiding anesthesia management.
- interventionNames
- Device: medstrom仪器
Primary outcomes (1)
- measure
- Correlation between HRV and the Medstrom Instrument Pain Index
- timeFrame
- From the beginning to the end of the operation
- description
- The correlation between HRV and the pain index of the Medstrom instrument under sedation and muscle relaxation with Bis maintained at 40-60 and TOF maintained below 90%
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Timeframe \& Location: Patients treated at the First Medical Center of the Chinese PLA General Hospital between June 2025 and December 2026. 2\. Age: 18 to 65 years old. 3. Diagnosis: Pathologically confirmed colon cancer requiring laparoscopic radical resection. 4\. Physical Status: American Society of Anesthesiologists (ASA) Physical Status Class I-III. 5\. Informed Consent: Patients who voluntarily participate in the study and provide written informed consent. Exclusion Criteria: \- 1. Body Mass Index (BMI): BMI ≥ 30 kg/m². 2. Organ Dysfunction: Severe concomitant cardiac, pulmonary, hepatic, or renal dysfunction. 3\. 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: 1.Requirement for conversion to open surgery or other significant deviation from the planned laparoscopic approach due to intraoperative findings.
References
Publications (0)
Data not yet available