NCT07089017Not yet recruiting
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 · Last updated 27 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 12 Jul 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Chinese PLA General Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07089017
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Feb 2026 to the primary completion date, 1 Sept 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- 1. Body Mass Index (BMI): BMI ≥ 30 kg/m². 2. Organ Dysfunction: Severe concomitant cardiac, pulmonary, hepatic, or renal dysfunction.
- Current use of medications affecting autonomic nervous system function.
- 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.
Other illness
- 3\. Neurological Conditions:
- History of autonomic nervous system disorders.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.