The Effect of Transcutaneous Electric Acupoint Stimulation on Post-operative Nausea and Vomiting After Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- incidence of PONV
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant will be blinded to the treatment arm; all investigators and care providers will be blinded to the treatment arm. Only the anesthesiologist trained in acupuncture and administering the treatment will know the randomization group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Transcutaneous Electrical Acupoint Stimulation
Subjects in the "Transcutaneous Electrical Acupoint Stimulation" (TEAS) group will receive 20 minutes of TEAS via ES-130 beginning at the time ondansetron is administered (usually given 30 minutes before the end of surgery), for prevention of PONV.
干预措施: TEAS via ES-130 (Device)
No Transcutaneous Electrical Acupoint Stimulation
Subjects in the "No Transcutaneous Electrical Acupoint Stimulation" group will not receive any TEAS, although they will have the acupoints identified and ECG patches placed. The device will not be connected to the electrodes of the ES-130 device at the end of surgery, and no TEAS will be delivered.
干预措施: No TEAS (Other)
结局指标
主要结局
incidence of PONV
时间窗: up to 24 hours after surgery
measure the incidence of PONV in spinal surgery
severity of PONV
时间窗: up to 24 hours after surgery
use Verbal Rating Scale (VRS) score (0-10) to rate nausea
次要结局
- Time to first nausea/vomiting rescue medication(within 2 and 24 hours after surgery)
- incidence of adverse events(24 hours after surgery)
- opioid consumption (units of morphine equivalence)(2 and 24 hours after surgery)
研究者
Jyoti Pandya
M.D., Principal Investigatgor, Associate Attending
Ohio State University