ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting
- Conditions
- Postoperative Nausea and Vomiting
- Interventions
- Procedure: ST36 acupuncture
- Registration Number
- NCT05240482
- Lead Sponsor
- The Second Hospital of Anhui Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
- Female patients with an American Society of Anesthesia (ASA) physical status Ⅰ-Ⅲ
- Scheduled for elective bariatric surgery .
- lack of patient consent
- patients with contraindications for acupoint injection
- obesity due to endocrine disorder
- allergic diathesis for drugs used in the study
- serious illness (heart, lung, kidney, or liver)
- coagulation dysfunction
- pre-existing psychological disorder
- anticathartic , glucocorticoid or opiates medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ST36 acupoint injection group ST36 acupuncture Patients in the experimental group will receive bilateral ST36 injection with anisodamine 1ml/point Conventional treatment group ST36 acupuncture Patients in the placebo group will receive bilateral ST36 injection with normal saline 1ml/point
- Primary Outcome Measures
Name Time Method The incidence of PONV within the first 24 hours At 0-24 hours after surgery The incidence of PONV within the first 24 hours
- Secondary Outcome Measures
Name Time Method Postoperative hospitalization During hospital Days of hospital staying after surgery
Time to the first rescue antiemetics At 0-24 hours after surgery The time from extubation to the first rescue antiemetics
Consumption of propofol During the surgery The consumption of propofol during the surgery
Length of anesthesia At the end of anesthesia From beginning to the end of anesthesia
Length of surgery At the end of surgery From beginning to the end of surgery
Adverse events Within 3 months after surgery Any adverse events after surgery within postoperative 3 months
Pittsburgh Sleep Quality Index Before surgery and at the postoperative 3 months Pittsburgh Sleep Quality Index (PSQI) will be assessed the quality of sleep. The higher score means the lower quality of sleep.
The incidence and severity of PONV assessed at 2, 6, 48, and 72 hours after surgery At 0-24 hours after surgery The incidence and severity of PONV in the anesthesia intensive care unit (AICU) or during the ward.
Early recovery outcomes Before discharge Including the time of first drink, ambulate and flatus
Consumption of remifentanil During the surgery The consumption of remifentanil during the surgery
Consumption of cisatracurium During the surgery The consumption of cisatracurium during the surgery
Consumption of dexmedetomidine During the surgery The consumption of cisatracurium during the surgery
QoR-15 At 24 hours after surgery Quality of Recovery-15 (QoR-15) will be used to assess quality of recovery after anesthesia. Total score ranges from 0 to 150. A higher total score means better quality of recovery.
The usage of rescue antiemetic drugs Within 24 hours after surgery in anesthesia resuscitation unit Total usage of rescue antiemetic drugs after surgery
BMI Before surgery and at the postoperative 3 months Body mass index
Gastrointestinal Symptom Rating Scale Before surgery and at the 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 the postoperative 3 months Hamilton Depression Rating 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.
Hamilton Anxiety Rating Scale Before surgery and at the postoperative 3 months Hamilton Anxiety Rating 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.
Trial Locations
- Locations (1)
Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, China