Intraoperative phrenic nerve stimulation to reduce postoperative complications

Impact of Intraoperative Diaphragmatic Neuromodulation on Postoperative Complications in Neurosurgical Patients: A Prospective, Randomized Controlled Study

This study is testing if using phrenic nerve stimulation during brain surgery can help reduce complications like brain injury and breathing problems after the operation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Sanbo Brain Hospital (other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06518707 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of intraoperative phrenic nerve stimulation on postoperative complications in patients undergoing elective craniotomy. Participants will be randomly assigned to one of three groups: a control group without intervention, a group receiving phrenic nerve stimulation without total neuromuscular blockade, and a group with partial neuromuscular blockade. The study will assess postoperative brain injury, delirium, and pulmonary complications through various assessments, including diaphragm ultrasound and plasma biomarker analysis. The goal is to determine if this neuromodulation technique can improve patient outcomes after surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older undergoing elective supratentorial tumor resection surgery with a BMI of 30 or less.

Not a fit: Patients with known respiratory diseases, neuromuscular dysfunction, or preoperative cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative delirium and pulmonary complications in neurosurgical patients.

How similar studies have performed: While phrenic nerve stimulation has shown promise in preclinical studies, its application in this specific context is novel and largely untested.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years old;
* Body mass index ≤ 30 kg/㎡;
* American Society of Anesthesiologists Classification: I-II level;
* Patients who undergo elective supratentorial tumor resection surgery;
* Mechanical ventilation during operation ≥ 4h;
* Signed informed consent form;

Exclusion Criteria:

* With known respiratory diseases, such as chronic obstructive pulmonary disease, obstructive sleep apnea, asthma, etc.;
* History of respiratory infection within 6 months before surgery;
* Received invasive or non-invasive mechanical ventilation within 6 months;
* Contraindications to extracorporeal diaphragmatic pacemakers, such as pneumothorax, active pulmonary tuberculosis, and wearing a cardiac pacemaker;
* Diagnosis with neuromuscular dysfunction diseases such as Guillain-Barre syndrome, myasthenia gravis, muscle atrophy, etc.;
* Pregnant or lactating patients;
* Preoperative cognitive impairment, consciousness disorders.

Where this trial is running

Beijing, Beijing

• Beijing Sanbo Brain Hospital, Capital Medical University — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Zhonghua Shi, PhD, MD — Beijing Sanbo Brain Hospital
• Study coordinator: Zhonghua Shi, PhD, MD

Conditions: Neurosurgery, Phrenic Nerve Stimulation, Postoperative Delirium, Phrenic nerve stimulation, Postoperative delirium, Postoperative pulmonary complications