ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting

The Second Hospital of Anhui Medical University

Status: Completed

Conditions: Postoperative Nausea and Vomiting

Treatments: Procedure: ST36 acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05240482

YX2021-114

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female patients with an American Society of Anesthesia (ASA) physical status Ⅰ-Ⅲ
2. Scheduled for elective bariatric surgery .

Exclusion criteria

1. lack of patient consent
2. patients with contraindications for acupoint injection
3. obesity due to endocrine disorder
4. allergic diathesis for drugs used in the study
5. serious illness (heart, lung, kidney, or liver)
6. coagulation dysfunction
7. pre-existing psychological disorder
8. anticathartic , glucocorticoid or opiates medications

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Conventional treatment group

Placebo Comparator group

Description:

Patients in the placebo group will receive bilateral ST36 injection with normal saline 1ml/point

Treatment:

Procedure: ST36 acupuncture

ST36 acupoint injection group

Experimental group

Description:

Patients in the experimental group will receive bilateral ST36 injection with anisodamine 1ml/point

Treatment:

Procedure: ST36 acupuncture