ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting

Study Overview
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Brief Summary
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Postoperative nausea and vomiting (PONV) is particularly distressing although it is not a fatal postoperative complication. 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 laparoscopic sleeve gastrectomy. 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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Acupuncture has been used as a medical technique in China for at least 2,000 years. More recently, it's also been extensively used in managing headache, chronic back pain, and PONV in USA. ST36 acupuncture is reported to be an effective preventive treatment for postoperative nausea and vomiting (PONV). However, It is not clear if it could efficiently prevent PONV in female patient who has underwent 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. 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 with a computer-generated randomization sequence (http://www.randomization.com). Patients, surgeons, anesthesiologists, nursing staff, and the research assistant, were all blinded to the group assignment.

Official Title
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Zusanli (ST36) Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting in Women Following Bariatric Surgery: A Single-center Study

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Procedure: ST36 acupuncture


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-Ⅲ Scheduled for elective bariatric surgery . Exclusion Criteria: lack of patient consent patients with contraindications for acupoint injection obesity due to endocrine disorder allergic diathesis for drugs used in the study serious illness (heart, lung, kidney, or liver) coagulation dysfunction pre-existing psychological disorder anticathartic , glucocorticoid or opiates medications

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 |
| --- | --- |
| Placebo Comparator: Conventional treatment group<br>Patients in the placebo group will receive bilateral ST36 injection with normal saline 1ml/point | Procedure: ST36 acupuncture<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>|
| Experimental: ST36 acupoint injection group<br>Patients in the experimental group will receive bilateral ST36 injection with anisodamine 1ml/point | Procedure: ST36 acupuncture<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 of PONV within the first 24 hours | The incidence of PONV within the first 24 hours | At 0-24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the first rescue antiemetics | The time from extubation to the first rescue antiemetics | At 0-24 hours after surgery | 
| The incidence and severity of PONV assessed at 2, 6, 48, and 72 hours after surgery | The incidence and severity of PONV in the anesthesia intensive care unit (AICU) or during the ward. | At 0-24 hours after surgery | 
| Early recovery outcomes | Including the time of first drink, ambulate and flatus | Before discharge | 
| Consumption of propofol | The consumption of propofol during the surgery | During the surgery | 
| Consumption of remifentanil | The consumption of remifentanil during the surgery | During the surgery | 
| Consumption of cisatracurium | The consumption of cisatracurium during the surgery | During the surgery | 
| Consumption of dexmedetomidine | The consumption of cisatracurium during the surgery | During the surgery | 
| Length of anesthesia | From beginning to the end of anesthesia | At the end of anesthesia | 
| Length of surgery | From beginning to the end of surgery | At the end of surgery | 
| Postoperative hospitalization | Days of hospital staying after surgery | During hospital | 
| QoR-15 | Quality of Recovery-15 (QoR-15) will be used to assess quality of recovery after anesthesia. Total score ranges from 0 to 150. A higher total score means better quality of recovery. | At 24 hours after surgery | 
| The usage of rescue antiemetic drugs | Total usage of rescue antiemetic drugs after surgery | Within 24 hours after surgery in anesthesia resuscitation unit | 
| Adverse events | Any adverse events after surgery within postoperative 3 months | Within 3 months after surgery | 
| BMI | Body mass index | Before surgery and at the postoperative 3 months | 
| Pittsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index (PSQI) will be assessed the quality of sleep. The higher score means the lower quality of sleep. | Before surgery and at the 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 the postoperative 3 months | 
| Hamilton Depression Rating Scale | Hamilton Depression Rating 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 the postoperative 3 months | 
| Hamilton Anxiety Rating Scale | Hamilton Anxiety Rating 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 | 

 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 (ST36), anisodamine