Intraoperative Diaphragmatic Neuromodulation

Beijing Sanbo Brain Hospital

Status: Completed

Conditions: Neurosurgery; Phrenic Nerve Stimulation; Postoperative Delirium

Treatments: Other: Phrenic nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06518707

Dia-the-Brain

Details and patient eligibility

About

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.

Full description

【Background】Postoperative complications, such as delirium and pulmonary complications, commonly occur in patients undergoing craniotomy. In preclinical studies, phrenic nerve stimulation (i.e., diaphragmatic neuromodulation) has been reported to effectively mitigate brain injury and pulmonary complications. However, its intraoperative administration and its impact on postoperative complications in this population are largely unknown.

【Method】In this prospective, single-center, randomized controlled clinical trial, patients receiving elective craniotomy will be screened. Eligible patients will be randomly divided into three groups: 1) Control group (without any interventions); 2) Intraoperative phrenic nerve stimulation (PNS) without total neuromuscular blockade (Train-of-Four (TOF) = 0); 3) Intraoperative PNS with partial neuromuscular blockade (TOF in the range of 1-2). Diaphragm ultrasound will be performed to assess diaphragm function before surgery and at 24 hours and 48 hours after surgery, respectively. Postoperative delirium will be assessed daily using the 3D-CAM and CAM-ICU within 3 days. Plasma biomarkers of brain injury will also be tested at baseline, 24 hours, and 48 hours after surgery. Pulmonary complications will be diagnosed by three independent clinicians based on laboratory tests, imaging, and clinical signs.

【Aims and Hypothesis】The primary aims are to investigate the impact of intraoperative diaphragmatic neuromodulation on brain injury, including the occurrence of delirium and changes in biomarkers. The secondary aims are the incidence of postoperative pulmonary complications and other clinical outcomes. We hypothesize that intraoperative diaphragmatic neuromodulation could reduce brain injury induced by craniotomy, as well as the incidence of postoperative delirium and pulmonary complications.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Control group

No Intervention group

Description:

No intervention will be performed; all protocols during surgery will follow the clinical routine.

PNS + TOF 0

Experimental group

Description:

Patients in this group will receive PNS during surgery, with the train-of-four (TOF) maintained at a level of 0. Additionally, to ensure complete blockade of the neuromuscular system, the Post-Tetanic Count (PTC) will be monitored and maintained at less than or equal to 3 simultaneously.

Treatment:

Other: Phrenic nerve stimulation

PNS + TOF 1-2

Experimental group

Description:

Patients in this group will receive PNS during surgery, and the TOF will be maintained at levels 1-2. In this group, the neuromuscular junction will not be fully blocked.

Treatment:

Other: Phrenic nerve stimulation