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Intraoperative Diaphragmatic Neuromodulation

NCT06518707 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-09-04

No results posted yet for this study

Summary

This prospective, single-center, randomized controlled clinical trial aims to investigate the impact of intraoperative phrenic nerve stimulation (i.e., diaphragmatic neuromodulation) on postoperative complications in neurosurgical patients. The primary objective is to assess the effect on postoperative brain injury, including the development of delirium and changes in biomarkers. Additionally, the incidence of postoperative pulmonary complications will be investigated.

Conditions

  • Neurosurgery
  • Phrenic Nerve Stimulation
  • Postoperative Delirium

Interventions

OTHER

Phrenic nerve stimulation

A commercial phrenic nerve stimulation equipment will be used during surgery. Phrenic nerve stimulation intensity will be determined before surgery, ensuring significant diaphragm contraction under stimulation. The use of an electric knife will be avoided during surgery. Tidal volume, airway pressure, and vital signs will be monitored continuously.

Sponsors & Collaborators

  • Beijing Sanbo Brain Hospital

    lead OTHER

Principal Investigators

  • Zhonghua Shi, PhD, MD · Beijing Sanbo Brain Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-26
Primary Completion
2024-12-30
Completion
2025-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06518707 on ClinicalTrials.gov