Postoperative Nausea and Vomiting
Conditions
Keywords
postoperative nausea and vomiting, bariatric surgery, Zusanli (ST36), anisodamine
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.
Interventions
PROCEDUREST36 acupuncture
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 Second Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Outcomes will be evaluated by anesthesiologists who are blinded to the treatment allocation. Patients, investigators and observers will be blinded to the patient allocation throughout the entire study period.
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-Ⅲ 2. Scheduled for elective bariatric surgery .
Exclusion criteria
1. lack of patient consent 2. patients with contraindications for acupoint injection 3. obesity due to endocrine disorder 4. allergic diathesis for drugs used in the study 5. serious illness (heart, lung, kidney, or liver) 6. coagulation dysfunction 7. pre-existing psychological disorder 8. anticathartic , glucocorticoid or opiates medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Postoperative hospitalization | During hospital | Days of hospital staying after surgery |
| The usage of rescue antiemetic drugs | Within 24 hours after surgery in anesthesia resuscitation unit | Total usage of rescue antiemetic drugs after surgery |
| Adverse events | Within 3 months after surgery | Any adverse events after surgery within postoperative 3 months |
| Consumption of propofol | During the surgery | The consumption of propofol during the surgery |
| BMI | Before surgery and at the postoperative 3 months | Body mass index |
| 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 |
| Time to the first rescue antiemetics | At 0-24 hours after surgery | The time from extubation to the first rescue antiemetics |
| 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. |
| 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. |
| 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. |
Countries
China
Outcome results
None listed