Evaluation of the Feasibility of the Medstrom Medical Device in Laparoscopic Radical Colectomy for Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Correlation between HRV and the Medstrom Instrument Pain Index
研究概览
简要总结
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:
- 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);
- Whether integrated monitoring reduces intraoperative decision latency (e.g., accelerated pain detection) and mitigates inter-device interference (e.g., BIS distortion by neuromuscular agents);
- 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:
- Group T（Medstrom -guided）:an intervention group receiving continuous multimodal monitoring via Medstrom,
- 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.
详细描述
This prospective randomized controlled trial (RCT) aims to evaluate the feasibility and safety of the integrated Medstrom monitoring system for real-time, comprehensive assessment of pain, sedation level, and neuromuscular blockade (NMB) during laparoscopic radical colectomy. It addresses significant limitations of conventional fragmented monitoring systems, such as data conflicts between independent devices (e.g., BIS for sedation, TOF for NMB, HRV for pain), delayed clinical interpretation, and suboptimal resource utilization.
The Medstrom technology utilizes palmar/plantar PAM sensors to objectively quantify pain via skin conductance peaks (SCP). SCPs are generated by emotional sweating triggered via spinal nociceptive reflexes, offering key advantages: objective pain quantification (SCP amplitude correlates with stimulus intensity), rapid response (within 1-2 seconds to noxious stimuli), resilience against hemodynamic instability, temperature variations, or medications, and the unique capability to simultaneously output validated sedation and neuromuscular indices. This single-device integration aims to replace the need for separate BIS, TOF, and HRV monitors.
The study design involves 45 patients (adjusted for 10% dropout from n=40) aged 18-65 years with ASA physical status I-III and confirmed colon cancer, undergoing elective laparoscopic radical colectomy. Key exclusions include BMI ≥30, significant organ dysfunction, neurological/neuromuscular disorders, and pregnancy. Participants are randomized into two groups:
- Medstrom-Guided Group (Intervention): Continuous monitoring using palmar/plantar sensors with real-time display of integrated pain, sedation, and NMB indices guiding anesthesia management.
- Conventional Monitoring Group (Control): Standard care using separate BIS (target 40-60) + TOF + standard hemodynamic monitoring.
A standardized anesthesia protocol is employed for both groups: Induction with Propofol (1.5-2.5 mg/kg) + Sufentanil (0.2-0.4 μg/kg) + Rocuronium (0.6-1.0 mg/kg), and Maintenance with Propofol (4-12 mg/kg/h) + Remifentanil (0.1-0.2 μg/kg/min) + bolus Rocuronium/Sufentanil as needed. Data collection occurs at 8 critical intraoperative timepoints, including intubation, skin incision, pneumoperitoneum, surgical end, and pre/post supplemental sufentanil administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Timeframe & Location: Patients treated at the First Medical Center of the Chinese PLA General Hospital between June 2025 and December
- •2. Age: 18 to 65 years old.
- •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.
排除标准
- •Body Mass Index (BMI): BMI ≥ 30 kg/m².
- •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.
- •Pregnancy/Lactation: Pregnant or lactating women.
- •Recent Surgery: History of secondary surgery within the preceding month.
- •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.
研究组 & 干预措施
No Intervention: Group C
Standard care using separate BIS (target 40-60) + TOF + standard hemodynamic monitoring.
Experimental:Group T
Continuous monitoring using palmar/plantar sensors with real-time display of integrated pain, sedation, and NMB indices guiding anesthesia management.
干预措施: medstrom 仪器 (Device)
结局指标
主要结局
Correlation between HRV and the Medstrom Instrument Pain Index
时间窗: From the beginning to the end of the operation
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%
次要结局
- Heart rate(From the beginning to the end of the operation)
- The total amount of anesthetic drugs(From the beginning to the end of the operation)
- Interaction of related indicators(From the beginning to the end of the operation)
- Mean arterial pressure(From the beginning to the end of the operation)
研究者
Peiqi Wang
professor
Chinese PLA General Hospital