Clinical trial NCT05375721: Prevention of PONV With Traditional Chinese Medicine
Official title: ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting in Women Following Bariatric Surgery: A Multicentre, Randomised, Double-Blind Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: postoperative nausea and vomiting
bariatric surgery
Zusanli
anisodamine
obesity
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
name: Huashan Hospital
name: Henan Provincial People's Hospital
name: The Affiliated Hospital of Xuzhou Medical University
name: First Affiliated Hospital of Jinan University
name: Beijing Chao Yang Hospital
First posted: 2022-05-17
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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 criteria: 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

Primary outcomes:
measure: The incidence and severity of PONV
timeFrame: At 0-2 hours after surgery
measure: The incidence and severity of PONV
timeFrame: At 2-6 hours after surgery
measure: The incidence and severity of PONV
timeFrame: At 6-12 hours after surgery
measure: The incidence and severity of PONV
timeFrame: At 12-24 hours after surgery
measure: The usage of rescue antiemetic drugs
timeFrame: During 3 months after bariatric surgery
Secondary outcomes:
measure: 15-item Quality of Recovery(QoR-15)
timeFrame: Postoperative 24 hours
measure: Postoperative pain
timeFrame: At 0-24 and 24-72 hours after surgery
measure: Consumption of analgesics
timeFrame: During 3 months after bariatric surgery
measure: Ambulation time
timeFrame: Postoperative 1-3 days
measure: Postoperative food and water intake time
timeFrame: Postoperative 1-3 days
measure: Postoperative hospitalization duration
timeFrame: 2 weeks after surgery
measure: Pittsburgh sleep quality index
timeFrame: Before surgery and at postoperative 3 months
measure: Gastrointestinal Symptom Rating Scale
timeFrame: Before surgery and at postoperative 3 months
measure: Hamilton depression rating scale
timeFrame: Before surgery and at postoperative 3 months
measure: Hamilton anxiety rating scale
timeFrame: Before surgery and at postoperative 3 months
measure: The MOS item short from health survey ,SF-36
timeFrame: Before surgery and at the postoperative 3 months.The scale consists of 36 items，divided into 8 sections，score of each section ranges from 0 to 100, the higher the score is, the healthier is.
Other outcomes:
measure: Consumption of propofol
timeFrame: During the bariatric surgery
measure: Consumption of remifentanil
timeFrame: During the surgery
measure: Consumption of sufentanil
timeFrame: During the surgery and postoperative 1-3 days
measure: Duration of anesthesia
timeFrame: At the end of anesthesia
measure: Duration of surgery
timeFrame: At the end of surgery
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
Study officials:
affiliation: The Second Hospital of Anhui Medical University
name: Ye Zhang, M.D
role: PRINCIPAL_INVESTIGATOR
References: