Effect of TEAS on PONV After Spinal Surgery

Официальное название

The Effect of Transcutaneous Electric Acupoint Stimulation on Post-operative Nausea and Vomiting After Spinal Surgery

Обзор

The proposed research will utilize electroacupuncture, a type of needleless acupuncture that uses electrostimulation, in a randomized, double blind study, to evaluate the incidence of post-operative nausea and vomiting (PONV) in patients undergoing spinal surgeries with the transcutaneous electrical acupoint stimulation (TEAS) compared to patients without TEAS.

Подробное описание

The rates of PONV will be evaluated over the first 24 hours after surgery, opioid consumption in units of morphine equivalence, and any adverse side effects will be recorded. Subjects who are included in the research will be randomly assigned to one of two groups - one group is the control group, receiving no TEAS, and the other group receiving TEAS. An anesthesiologist trained in acupuncture will utilize the Excel Pointer to locate the specific acupoints previously identified as associated with prevention PONV. Anesthesiologist will place electrocardiogram (ECG) pads at the identified acupoints prior to surgery. Subjects will be connected to the ES-130 (electro-therapy) device upon entering the operating room. Prior to the surgical closure, the unblinded researcher will initiate delivery of TEAS, or not, according to study protocol based on the randomization group of the participant. The anesthesiologist will not know the group assignment. At the end of surgery, the subject will be disconnected from the ES-130 and the ECG pads will be carefully removed. Researchers will follow up with the subject in recovery regarding any occurrence and severity of PONV, adverse events, and verbal pain scores, until 24 hours after end of surgery.

Вмешательства

• Устройство TEAS via ES-130
  Transcutaneous Electrical Acupoint Stimulation will be administered delivered by the ES-130 device for 20 minutes at the time ondansetron is given (typically 30 minutes before the end of surgery). Subjects randomized to this intervention will have the TEAS device connected to the previously placed ECG patches to deliver the stimulus.
• Другое No TEAS
  No Transcutaneous Electrical Acupoint Stimulation will be delivered to the subjects randomized to this group; ECG patches will be placed at the identified acupoints, however, no electrical stimulus will be delivered.

Первичные конечные точки

• incidence of PONV [Срок оценки: up to 24 hours after surgery]
• severity of PONV [Срок оценки: up to 24 hours after surgery]

Вторичные конечные точки (3)

• Time to first nausea/vomiting rescue medication [Срок оценки: within 2 and 24 hours after surgery]
• opioid consumption (units of morphine equivalence) [Срок оценки: 2 and 24 hours after surgery]
• incidence of adverse events [Срок оценки: 24 hours after surgery]

Критерии участия

Критерии включения

• Male and female patients , 18 or older
• American Society of Anesthesiologists (ASA) classification I or II or III
• Undergoing elective spinal surgery expected to last no more than four hours (from induction of anesthesia to extubation).
• Capable and willing to consent

Критерии исключения

• Neuraxial (intrathecal or epidural) block
• Significant ongoing history of vestibular disease or dizziness
• Nausea or vomiting within 24 hours prior to surgery, use of antiemetic or emetogenic drugs within 3 days of surgery
• Documented alcohol or substance abuse within 3 months before the surgery
• Limb abnormalities such as burn and amputation.
• Poorly controlled diabetes mellitus (fasting plasma glucose >126 mg/dL or <70 mg/dL)
• Implantation of metal/electrical devices, such as nerve stimulator, cardiac pacemaker, cardioverter, defibrillator and internal hearing aids
• Rash, local infection, keloid, any dermatologic condition that could interfere with the acupoint stimulation area
• Documented alcohol or substance abuse within 3 months before surgery
• Presence of clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, or schizophrenia
• Chemotherapy or radiation therapy within 7 days before surgery
• Investigational product use within 3 months prior surgery
• Any condition, which in the opinion of the investigator would make subject ineligible for participation in the study (history of unstable cardiovascular, pulmonary, renal, hepatic, seizures)
• Special population (prisoners, pregnant and lactating women)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• The Ohio State University Wexner Medical Center — Columbus

Идентификаторы

NCT: NCT03187535 · 2017H0101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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