Anesthetic Management Guided by the Medstrom Instrument

NCT07089017 | Not Yet Recruiting

• 1 other identifier: PLAGH-L03
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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. 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).
4. 4.Group T（Medstrom -guided）:an intervention group receiving continuous multimodal monitoring via Medstrom,
5. 5.Group C (Conventional):a control group undergoing conventional monitoring (BIS + TOF + hemodynamic parameters).

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• Correlation between HRV and the Medstrom Instrument Pain Index

  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%

  From the beginning to the end of the operation

Secondary Outcomes (4)

• 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

Study Arms (2)

No Intervention: Group C

NO INTERVENTION

Standard care using separate BIS (target 40-60) + TOF + standard hemodynamic monitoring.

Experimental:Group T

EXPERIMENTAL

Continuous monitoring using palmar/plantar sensors with real-time display of integrated pain, sedation, and NMB indices guiding anesthesia management.

Device: medstrom仪器

Interventions

medstrom仪器 DEVICE

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.

Experimental:Group T

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pei qi Wang

  The Firsst Medical Center ,Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei qi Wang

CONTACT

0086+13141307586; qiqi218@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 28, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share