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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
300
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).
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGThe First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGThe Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
NOT_YET_RECRUITINGBeijing Chao-Yang Hospital, Capital Medical University
Beijing, China
NOT_YET_RECRUITINGHuashan Hospital Affiliated to Fudan University
Shanghai, China
NOT_YET_RECRUITINGThe incidence and severity of PONV
The incidence and severity of PONV after bariatric surgery
Time frame: At 0-2 hours after surgery
The incidence and severity of PONV
Total usage of rescue antiemetic drugs after bariatric surgery
Time frame: At 2-6 hours after surgery
The incidence and severity of PONV
The incidence and severity of PONV after bariatric surgery
Time frame: At 6-12 hours after surgery
The incidence and severity of PONV
The incidence and severity of PONV after bariatric surgery
Time frame: At 12-24 hours after surgery
The usage of rescue antiemetic drugs
Total usage of rescue antiemetic drugs after bariatric surgery
Time frame: During 3 months after bariatric surgery
15-item Quality of Recovery(QoR-15)
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.
Time frame: Postoperative 24 hours
Postoperative pain
Patients will be asked about their pain level at rest and moving on a numeric rating scale (0=no pain,10=worst pain imaginable) .
Time frame: At 0-24 and 24-72 hours after surgery
Consumption of analgesics
Cumulative analgesic consumption after surgery
Time frame: During 3 months after bariatric surgery
Ambulation time
Interval time of patients' transit from bed rest to ambulation after surgery
Time frame: Postoperative 1-3 days
Postoperative food and water intake time
Duration of eating and drinking after surgery
Time frame: Postoperative 1-3 days
Postoperative hospitalization duration
Days of hospital staying after surgery
Time frame: 2 weeks after surgery
Pittsburgh sleep quality index
Pittsburgh sleep quality index will be used to evaluate quality of sleep. The higher score means the lower quality of sleep.
Time frame: Before surgery and at postoperative 3 months
Gastrointestinal Symptom Rating Scale
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 .
Time frame: Before surgery and at postoperative 3 months
Hamilton depression rating scale
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.
Time frame: Before surgery and at postoperative 3 months
Hamilton anxiety rating scale
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.
Time frame: Before surgery and at postoperative 3 months
The MOS item short from health survey ,SF-36
Concise health status scale
Time frame: 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.
Qi Xue, Ph.D
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