Postoperative Nausea and Vomiting
Conditions
Keywords
postoperative nausea and vomiting, bariatric surgery, Zusanli, anisodamine, obesity
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.
Interventions
PROCEDUREST36 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).
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Huashan Hospital
Henan Provincial People's Hospital
The Affiliated Hospital of Xuzhou Medical University
First Affiliated Hospital of Jinan University
Beijing Chao Yang Hospital
The Second Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence and severity of PONV | At 0-2 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative food and water intake time | Postoperative 1-3 days | Duration of eating and drinking after surgery |
| 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. |
| 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. |
| 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. |
| 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 |
| 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 hospitalization duration | 2 weeks after surgery | Days of hospital staying after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of anesthesia | At the end of anesthesia | From beginning to the end of anesthesia |
| Duration of surgery | At the end of surgery | From beginning to the end of surgery |
| Consumption of remifentanil | During the surgery | The total consumption of remifentanil during the surgery |
| Consumption of propofol | During the bariatric surgery | The total consumption of propofol during the surgery |
| Consumption of sufentanil | During the surgery and postoperative 1-3 days | The total consumption of sufentanil during the surgery |
Countries
China
Contacts
Primary ContactChunxia Huang, Ph.D
Backup ContactQi Xue, Ph.D
Outcome results
None listed