Transcranial electrostimulation to reduce pain after OSA surgery

The Effects of Transcranial Electrostimulation (TES) on Postoperative Pain and Functional Patient Outcomes After Surgery for Obstructive Sleep Apnea Syndrome

This will test whether a weak electrical current applied to the scalp can reduce postoperative pain and help people recover faster after major OSA surgeries like palatopharyngoplasty or maxillomandibular advancement.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Locations: 1 site (Stanford, California)
• Trial ID: NCT03735004 on ClinicalTrials.gov

What this trial studies

The study applies noninvasive transcranial electrostimulation (TES) to the scalp of patients undergoing major airway surgery for moderate-to-severe obstructive sleep apnea (PPP or MMA) and monitors postoperative pain and recovery measures. Outcomes include pain intensity (VAS), opioid consumption, wound healing, and functional recovery recorded in hospital and by home diaries. Patients will be selected from ASA physical status II–III adults who can provide informed consent and complete study instruments; individuals with seizure history, certain psychiatric or brain/eye disorders, pregnancy, or substance abuse are excluded. The goal is to determine whether TES can provide non-pharmacological analgesia and reduce reliance on opioids in this high-risk surgical population.

Who should consider this trial

Good fit: Adults with moderate-to-severe OSA scheduled for palatopharyngoplasty or maxillomandibular advancement who are ASA II–III and able to consent and complete pain diaries are ideal candidates.

Not a fit: Patients who are pregnant, have a history of seizures, significant brain or psychiatric disease, certain eye/head injuries, or who cannot complete pain scales or diaries are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, TES could reduce postoperative pain, lower opioid use and related respiratory risks, and speed return to normal activities after OSA surgery.

How similar studies have performed: Some noninvasive cranial electrical stimulation approaches have shown modest pain-relief effects in other settings, but applying TES specifically after major OSA airway surgery is relatively novel and not yet well established.

Eligibility criteria

Inclusion Criteria: Patients with moderate-to-severe OSA, presenting for PPP and MMA surgeries. All patients will be American Society of Anesthesiology (ASA) physical status II-III. The subjects should understand informed consent and study instructions.

Exclusion Criteria:

1. Patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to Sevoflurane, an inhaled anesthetic agent.
2. Pregnant patients.
3. Patients who are unable to understand the questionnaires or the visual analogue scale (VAS) pain scores, or to keep home diaries.
4. Patients with clinically-significant psychological disorders, psychiatric illness or treatment.
5. Alcohol and drug-abusing patients.
6. Patients with the history of seizures.
7. Patients with the documented or suspected organic brain or psychiatric disease, in particular with the history of hallucinations and delusions.
8. Patients with history of significant eye disease, or head or eye injury, which led to alteration of the cranial anatomy or metallic intracranial implants.
9. Patients with the history of significant surgery of the head and/or eye.
10. Patients with skin lesions and/or defects over the areas where TES electrodes will be applied.
11. Patients with implanted medical devices, including cardiac pacemakers.
12. Patients who participate in other research protocols that may interfere with the study outcomes and objectives.
13. Other patients that may be excluded by the investigator, based on medical history and physical examination.

Where this trial is running

Stanford, California

• Stanford Univeristy Medical Center — Stanford, California, United States (Recruiting)

Study contacts

• Principal investigator: Vladimir Nekhendzy, MD — Stanford University

Conditions Transcranial Electrical Stimulation; electrical stimulation; electric anesthesia