ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting

NCT ID: NCT05240482

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-20
• Study Completion Date: 2022-07-06

Brief Summary

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

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.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Conventional treatment group

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

Group Type: PLACEBO_COMPARATOR

ST36 acupuncture

Intervention Type: PROCEDURE

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).

ST36 acupoint injection group

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

Group Type: EXPERIMENTAL

ST36 acupuncture

Intervention Type: PROCEDURE

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).

Interventions

ST36 acupuncture

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).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

hui hou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ye Zhang, M.D.

Role: STUDY_CHAIR

The Second Hospital of Anhui Medical University

Locations

Second Affiliated Hospital of Anhui Medical University

Hefei, , China

Countries

China

Other Identifiers

YX2021-114

Identifier Type: -

Identifier Source: org_study_id