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Prevention of PONV With Traditional Chinese Medicine

Recruiting
18 - 65 years of age
Female
Phase N/A

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Overview

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.

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.

Eligibility

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

Study details

Postoperative Nausea and Vomiting

NCT05375721

The Second Hospital of Anhui Medical University

25 January 2024

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