Prevention of PONV With Traditional Chinese Medicine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Procedure: ST36 acupoint injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ST36 acupoint injection group<br>Patients in this group will received bilateral ST36 injection with scopolamine 1ml/point | Procedure: ST36 acupoint injection<br>* 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).<br>|
| Placebo Comparator: pharmacoprophylaxis group<br>Patients in this group will received bilateral ST36 acupoint injection with normal saline 1ml/point | Procedure: ST36 acupoint injection<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of PONV | The incidence and severity of PONV after bariatric surgery | At 0-2 hours after surgery | 
| The incidence and severity of PONV | Total usage of rescue antiemetic drugs after bariatric surgery | At 2-6 hours after surgery | 
| The incidence and severity of PONV | The incidence and severity of PONV after bariatric surgery | At 6-12 hours after surgery | 
| The incidence and severity of PONV | The incidence and severity of PONV after bariatric surgery | At 12-24 hours after surgery | 
| The usage of rescue antiemetic drugs | Total usage of rescue antiemetic drugs after bariatric surgery | During 3 months after bariatric surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 15-item Quality of Recovery(QoR-15) | 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. | Postoperative 24 hours | 
| Postoperative pain | Patients will be asked about their pain level at rest and moving on a numeric rating scale (0=no pain,10=worst pain imaginable) . | At 0-24 and 24-72 hours after surgery | 
| Consumption of analgesics | Cumulative analgesic consumption after surgery | During 3 months after bariatric surgery | 
| Ambulation time | Interval time of patients' transit from bed rest to ambulation after surgery | Postoperative 1-3 days | 
| Postoperative food and water intake time | Duration of eating and drinking after surgery | Postoperative 1-3 days | 
| Postoperative hospitalization duration | Days of hospital staying after surgery | 2 weeks after surgery | 
| Pittsburgh sleep quality index | Pittsburgh sleep quality index will be used to evaluate quality of sleep. The higher score means the lower quality of sleep. | Before surgery and at postoperative 3 months | 
| Gastrointestinal Symptom Rating Scale | 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 . | Before surgery and at postoperative 3 months | 
| Hamilton depression rating scale | 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. | Before surgery and at postoperative 3 months | 
| Hamilton anxiety rating scale | 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 postoperative 3 months | 
| The MOS item short from health survey ,SF-36 | Concise health status scale | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative nausea and vomiting, bariatric surgery, Zusanli, anisodamine, obesity