Transcranial Electrostimulation and Obstructive Sleep Apnea Surgery

NCT03735004 | Unknown DMC FDA Device

• 1 other identifier: 29984
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

electrical stimulation; electric anesthesia

Outcome Measures

Primary Outcomes (4)

• Opioid requirements during first postoperative TES session

  IV morphine milligram equivalents

  Recorded during a 20 min TES session administered for first moderate-to-severe postoperative pain in the recovery room

• Pain scores during first postoperative TES session

  VAS pain scores (Pain measured using 11-point visual analog scale 0-10, 0 no pain, 10 worst pain imaginable).

  Recorded during a 20 min TES session administered for first moderate-to-severe postoperative pain in the recovery room

• Postoperative opioid consumption during recovery room stay

  IV morphine milligram equivalents

  Through the recovery room stay, on average 2.5 hours

• Postoperative pain scores during recovery room stay

  VAS pain scores

  Through the recovery room stay, on average 2.5 hours

Secondary Outcomes (6)

• Postoperative opioid consumption during hospital stay

  From "floor ready" until hospital discharge, on average 2 days

• Post-discharge postoperative opioid consumption

  From hospital discharge to up to 4 weeks postoperatively

• Time to start of soft diet

  Day of surgery to starting a soft diet (up to 7 days)

• Time to return to daily activities

  Day of surgery to return to daily activities (up to 10 days)

• Time to return to work

  From the day of surgery to return to work (up to 21 days)

Study Arms (3)

TES 60 Hz DC:AC

EXPERIMENTAL

Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current

Device: Transcranial electrostimulation (TES)

TES 100 Hz DC:AC

ACTIVE COMPARATOR

Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current

Device: Transcranial electrostimulation (TES)

TES with DC current

SHAM COMPARATOR

Transcranial electrostimulation (TES) with direct current (DC) only

Device: Transcranial electrostimulation (TES)

Interventions

Transcranial electrostimulation (TES) DEVICE

Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC) current, or TES with DC only will be administered through the skin electrodes positioned on the patient's head

TES 100 Hz DC:AC; TES 60 Hz DC:AC; TES with DC current

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Univeristy Medical Center

Stanford, California, 94305, United States

RECRUITING

Study Officials

• Vladimir Nekhendzy, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Anesthesiology and Otolaryngology

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 8, 2018
• Study Start: July 18, 2017
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)