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临床试验/NCT03735004
NCT03735004已完成不适用

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

Stanford University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年7月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Postoperative pain scores during recovery room stay

研究概览

简要总结

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.

详细描述

The incidence and severity of postoperative pain in patients undergoing major airway surgery for OSA, such as palatopharyngoplasty (PPP) and maxillomandibular advancement (MMA) is high, and may persist for days, significantly contributing to patient's morbidity. High doses of intravenous and oral opioids are frequently required to achieve adequate pain relief. Yet, the increased sensitivity of OSA patients to opioid analgesics, and associated high risk of postoperative respiratory depression and upper airway obstruction limit the traditional therapeutic options, frequently making pain control after PPP and MMA surgery suboptimal.

The effect of significant postoperative pain on surgical outcomes is multifold. Poorly controlled post-surgical pain increases patient morbidity, impairs wound healing, and negatively affects patient recovery and functional outcomes, such as ambulation, a resumption of a normal oral intake, a return to normal daily activities, a return to work, and others. Side effects of opioid medications, such as urinary retention, constipation, nausea, vomiting, dizziness, and itching may further adversely affect recovery and cause patient dissatisfaction with the surgical procedure.

The development of the new, effective analgesic modalities, is therefore highly desirable for OSA surgical patients, and particularly those undergoing PPP and MMA surgeries. Transcranial electrostimulation (TES) is a non-invasive brain stimulation technique that employs administration of a weak electrical current (≤ 5 mA) through the electrodes positioned on the skin of the patient's head. TES is a safe procedure, with a low risk of associated, minor side effects It is widely believed that TES with combined direct (DC) and alternating (AC) current (TES DC:AC) triggers the release of endogenous opioids and other central neurotransmitters (e.g. norepinephrine) that interrupt nociceptive processing. The investigator's previous studies have demonstrated that TES DC:AC produces quickly evolving, effective non-pharmacological analgesia, without associated respiratory depression or other opioid-induced side effects. If analgesic effect of TES can be demonstrated in this study, the TES may become an attractive adjunct for postoperative analgesic treatment for OSA patients, allowing for improved quality of analgesia and enhanced recovery.

Moreover, demonstrating TES analgesic effect may facilitate its widespread use as a non-pharmacological analgesic adjunct postoperatively, especially in elderly patients, who have a high incidence of associated OSA and sensitivity to systemic opioids. The incidence of OSA in general surgical population reaches over 20%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

TES 60 Hz DC:AC

Experimental

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

干预措施: Transcranial electrostimulation (TES) (Device)

TES 100 Hz DC:AC

Active Comparator

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

干预措施: Transcranial electrostimulation (TES) (Device)

TES with DC current

Sham Comparator

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

干预措施: Transcranial electrostimulation (TES) (Device)

结局指标

主要结局

Postoperative pain scores during recovery room stay

时间窗: Through the recovery room stay, on average 2.5 hours

VAS pain scores

Opioid requirements during first postoperative TES session

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

IV morphine milligram equivalents

Pain scores during first postoperative TES session

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

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

Postoperative opioid consumption during recovery room stay

时间窗: Through the recovery room stay, on average 2.5 hours

IV morphine milligram equivalents

Opioid Requirements During First Postoperative TES Session

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

IV morphine milligram equivalents

Pain Scores During First Postoperative TES Session

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

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

Postoperative Opioid Consumption During Recovery Room Stay

时间窗: During the recovery room stay until "floor ready" (on average 2.5 hours)

IV morphine milligram equivalents

Postoperative Pain Scores During Recovery Room Stay

时间窗: During the recovery room stay until "floor ready" (on average 2.5 hours)

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

次要结局

  • Time to start of soft diet(Day of surgery to starting a soft diet (up to 7 days))
  • Time to return to work(From the day of surgery to return to work (up to 21 days))
  • Postoperative opioid consumption during hospital stay(From "floor ready" until hospital discharge, on average 2 days)
  • Time to return to daily activities(Day of surgery to return to daily activities (up to 10 days))
  • Post-discharge postoperative opioid consumption(From hospital discharge to up to 4 weeks postoperatively)
  • Change from baseline in QoR15 score (Quality of Recovery 15-question score)(Baseline (before surgery) to postoperative week 4.)
  • Time to Return to Work(From the day of surgery to return to work to postoperative week 4.)
  • Time to Return to Daily Activities(Day of surgery to return to daily activities to postoperative week 4.)
  • Postoperative Opioid Consumption During Post-operative Day 0(From "floor ready" until midnight of the day after surgery (POD#0, (postoperative day #0).)
  • Post-discharge Postoperative Opioid Consumption(From POD#1 through the 1st postoperative week after surgery.)
  • Time to Discharge From the Recovery Room(Day of surgery (postoperative day #0, POD#0).)
  • Time to Start of Soft Diet(Day of surgery to starting a soft diet (up to 7 days postoperative))
  • Change From Baseline in QoR15 Score (Quality of Recovery 15-question Score)(Baseline (before surgery) to postoperative week 4.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vladimir Nekhendzy

Clinical Professor of Anesthesiology and Otolaryngology

Stanford University

研究点 (2)

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