Transcranial Electrostimulation and Obstructive Sleep Apnea Surgery

Description

Postoperative pain after major surgery for obstructive sleep apnea (OSA), such as palatopharyngoplasty (PPP) and maxillomandibular advancement (MMA) is moderate-to-severe, and may persist for weeks. Control of this pain may be difficult, because OSA patients are very sensitive to traditional opioid pain medications, and their side effects. Poorly controlled pain slows down patients' recovery after surgery, including a return to normal daily activities and work, and may also delay wound healing. This study will investigate whether pain relief and recovery after surgery may be improved with the application of a weak electrical current to the skin of the patient's head (transcranial electrostimulation, TES). The TES works by blocking pain in the central nervous system through multiple mechanisms, which result in non-pharmacological pain relief, without drug-associated side effects.

Conditions

Transcranial Electrical Stimulation

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Study Overview

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Study Details

Study overview

Postoperative pain after major surgery for obstructive sleep apnea (OSA), such as palatopharyngoplasty (PPP) and maxillomandibular advancement (MMA) is moderate-to-severe, and may persist for weeks. Control of this pain may be difficult, because OSA patients are very sensitive to traditional opioid pain medications, and their side effects. Poorly controlled pain slows down patients' recovery after surgery, including a return to normal daily activities and work, and may also delay wound healing. This study will investigate whether pain relief and recovery after surgery may be improved with the application of a weak electrical current to the skin of the patient's head (transcranial electrostimulation, TES). The TES works by blocking pain in the central nervous system through multiple mechanisms, which result in non-pharmacological pain relief, without drug-associated side effects.

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

Transcranial Electrostimulation and Obstructive Sleep Apnea Surgery

Condition
Transcranial Electrical Stimulation
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford Univeristy Medical Center, Stanford, California, United States, 94305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Vladimir Nekhendzy, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2024-08-31