Prevention of PONV With Traditional Chinese Medicine
- Conditions
- Postoperative Nausea and Vomiting
- Interventions
- Procedure: ST36 acupoint injection
- Registration Number
- NCT05375721
- Lead Sponsor
- The Second Hospital of Anhui Medical University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- Female patients with an American Society of Anesthesia (ASA) physical status I-IV
- Scheduled for elective bariatric surgery
- Written informed consent was obtained
- Patients with contraindications for acupoint injection
- Difficulty in communicating with patients
- Allergic diathesis for drugs used in the study or serious illness (heart, lung, kidney, or liver, et. al)
- Coagulation dysfunction
- Pre-existing psychological or neurological disorder
- Pre-use medicine before surgery that would interferenced objective assessment (including the use of opioids, antiemetics or glucocorticoids)
- Gastroesophageal reflux disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ST36 acupoint injection group ST36 acupoint injection Patients in this group will received bilateral ST36 injection with scopolamine 1ml/point pharmacoprophylaxis group ST36 acupoint injection Patients in this group will received bilateral ST36 acupoint injection with normal saline 1ml/point
- Primary Outcome Measures
Name Time Method The incidence and severity of PONV At 12-24 hours after surgery The incidence and severity of PONV after bariatric surgery
The usage of rescue antiemetic drugs During 3 months after bariatric surgery Total usage of rescue antiemetic drugs after bariatric surgery
- Secondary Outcome Measures
Name Time Method Postoperative hospitalization duration 2 weeks after surgery Days of hospital staying after surgery
Hamilton anxiety rating scale Before surgery and at postoperative 3 months Hamilton anxiety scale (HAM-A) will be used to assess anxiety. Total score ranges from 0 to 56, the higher the score is, the more serious the anxiety is.
Pittsburgh sleep quality index Before surgery and at postoperative 3 months Pittsburgh sleep quality index will be used to evaluate quality of sleep. The higher score means the lower quality of sleep.
15-item Quality of Recovery(QoR-15) Postoperative 24 hours QoR-15 will be used to evaluate recovery quality after anesthesia, including 15 items covering sleep, satisfaction, emotion and pain et. al,total score ranges from 0 to 150,the higher score means the higher quality of recovery.
Postoperative pain At 0-24 and 24-72 hours after surgery Patients will be asked about their pain level at rest and moving on a numeric rating scale (0=no pain,10=worst pain imaginable) .
Consumption of analgesics During 3 months after bariatric surgery Cumulative analgesic consumption after surgery
Ambulation time Postoperative 1-3 days Interval time of patients' transit from bed rest to ambulation after surgery
Postoperative food and water intake time Postoperative 1-3 days Duration of eating and drinking after surgery
Gastrointestinal Symptom Rating Scale Before surgery and at postoperative 3 months Gastrointestinal symptom rating scale (GSRS) will be used to assess gastrointestinal function. The score ranges from 0 to 45. The higher score means poorer gastrointestinal function .
Hamilton depression rating scale Before surgery and at postoperative 3 months Hamilton depression scale (HAMD) will be used to assess depression. HAMD 24 item version score range 0-96. The higher score means the higher possibility of depression.
The MOS item short from health survey ,SF-36 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. Concise health status scale
Trial Locations
- Locations (7)
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Guangdong, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Beijing Chao-Yang Hospital, Capital Medical University
🇨🇳Beijing, China
Huashan Hospital Affiliated to Fudan University
🇨🇳Shanghai, China