Prevention of PONV With Traditional Chinese Medicine

The Second Hospital of Anhui Medical University

Status: Enrolling

Conditions: Postoperative Nausea and Vomiting

Treatments: Procedure: ST36 acupoint injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05375721

YX2021-152（F1）

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated 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-IV
2. Scheduled for elective bariatric surgery
3. Written informed consent was obtained

Exclusion criteria

1. Patients with contraindications for acupoint injection
2. Difficulty in communicating with patients
3. Allergic diathesis for drugs used in the study or serious illness (heart, lung, kidney, or liver, et. al)
4. Coagulation dysfunction
5. Pre-existing psychological or neurological disorder
6. Pre-use medicine before surgery that would interferenced objective assessment (including the use of opioids, antiemetics or glucocorticoids)
7. Gastroesophageal reflux disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

ST36 acupoint injection group

Experimental group

Description:

Patients in this group will received bilateral ST36 injection with scopolamine 1ml/point

Treatment:

Procedure: ST36 acupoint injection

pharmacoprophylaxis group

Placebo Comparator group

Description:

Patients in this group will received bilateral ST36 acupoint injection with normal saline 1ml/point

Treatment:

Procedure: ST36 acupoint injection