Prevention of PONV With Traditional Chinese Medicine

ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting in Women Following Bariatric Surgery: A Multicentre, Randomised, Double-Blind Controlled Trial.

The First Affiliated Hospital with Nanjing Medical University, Huashan Hospital, Henan Provincial People's Hospital, The Affiliated Hospital of Xuzhou Medical University, First Affiliated Hospital of Jinan University, Beijing Chao Yang Hospital

Postoperative nausea and vomiting (PONV) is particularly one of the most common complications after laparoscopic sleeve gastrectomy (LSG). It can lead to serious adverse events and delayed activity, and prolong the time of rehabilitation and discharge. Numbers of studies have been focused on identifying risk factors and therapies of PONV. Unfortunately, there' no consistent comments for PONV prevention in women after LSG. Notably, Zusanli (ST36) acupoint and anisodamine have been evidenced to treat various gastrointestinal conditions. The primary outcome of this study was to evaluate the impact of anisodamine injection in ST36 on PONV in women following bariatric surgery.

At the onset of this investigation, we have already identified several methodologic issues, such as the timing of the acupuncture intervention, sample size, perioperative anesthetic techniques, and appropriate control groups. All subjects were randomly assigned to the following two groups: ST36 acupoint injection group (bilateral ST36 acupoint injection with scopolamine); pharmacoprophylaxis group (bilateral ST36 injection with normal saline). The primary outcome of this study was the total incidence of PONV during the hospital and after the discharge. Participants were randomly assigned into different groups according to the computer-generated randomization sequence (http://www.randomization.com). Patients, surgeons, care givers, anesthesiologists, nursing staff, and outcomes assessor, were all blinded to the group assignment.

ST36 is located on the lateral surface of leg, 3 cun distal to the lower border of the patella, 1 finger-breadth lateral to the anterior crest of the tibia, between the tibialis anterior muscle and the tendon of the extensor digitorum longus. (The breadth of patient's middle finger was the proportional unit of measure "the cun", defined as the distance between the two medial ends of the creases of the interphalangeal joints when the patient's middle finger is flexed).

QoR-15 will be used to evaluate recovery quality after anesthesia, including 15 items covering sleep, satisfaction, emotion and pain et. al,total score ranges from 0 to 150,the higher score means the higher quality of recovery.

Patients will be asked about their pain level at rest and moving on a numeric rating scale (0=no pain,10=worst pain imaginable) .

Pittsburgh sleep quality index will be used to evaluate quality of sleep. The higher score means the lower quality of sleep.

Gastrointestinal symptom rating scale (GSRS) will be used to assess gastrointestinal function. The score ranges from 0 to 45. The higher score means poorer gastrointestinal function .

Hamilton depression scale (HAMD) will be used to assess depression. HAMD 24 item version score range 0-96. The higher score means the higher possibility of depression.

Hamilton anxiety scale (HAM-A) will be used to assess anxiety. Total score ranges from 0 to 56, the higher the score is, the more serious the anxiety is.

Before surgery and at the postoperative 3 months.The scale consists of 36 items，divided into 8 sections，score of each section ranges from 0 to 100, the higher the score is, the healthier is.

Inclusion Criteria: Female patients with an American Society of Anesthesia (ASA) physical status I-IV Scheduled for elective bariatric surgery Written informed consent was obtained Exclusion Criteria: Patients with contraindications for acupoint injection Difficulty in communicating with patients Allergic diathesis for drugs used in the study or serious illness (heart, lung, kidney, or liver, et. al) Coagulation dysfunction Pre-existing psychological or neurological disorder Pre-use medicine before surgery that would interferenced objective assessment (including the use of opioids, antiemetics or glucocorticoids) Gastroesophageal reflux disease

ChunXia Huang and Ye Zhang will review requests and criteria to share IPD. Requests are to be sent by email to huangchunxia@ahmu.edu.cn or zhangye_hassan@sina.com.