Prevention of PONV With Traditional Chinese Medicine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-23

Study Completion Date

2024-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ST36 acupoint injection group

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

Group Type EXPERIMENTAL

ST36 acupoint injection

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).

pharmacoprophylaxis group

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

Group Type PLACEBO_COMPARATOR

ST36 acupoint injection

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

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ST36 acupoint injection

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

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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hui hou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ye Zhang, M.D

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Anhui Medical University

Locations

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The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING