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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
90
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).
Second Affiliated Hospital of Anhui Medical University
Hefei, China
The incidence of PONV within the first 24 hours
The incidence of PONV within the first 24 hours
Time frame: At 0-24 hours after surgery
Time to the first rescue antiemetics
The time from extubation to the first rescue antiemetics
Time frame: At 0-24 hours after surgery
The incidence and severity of PONV assessed at 2, 6, 48, and 72 hours after surgery
The incidence and severity of PONV in the anesthesia intensive care unit (AICU) or during the ward.
Time frame: At 0-24 hours after surgery
Early recovery outcomes
Including the time of first drink, ambulate and flatus
Time frame: Before discharge
Consumption of propofol
The consumption of propofol during the surgery
Time frame: During the surgery
Consumption of remifentanil
The consumption of remifentanil during the surgery
Time frame: During the surgery
Consumption of cisatracurium
The consumption of cisatracurium during the surgery
Time frame: During the surgery
Consumption of dexmedetomidine
The consumption of cisatracurium during the surgery
Time frame: During the surgery
Length of anesthesia
From beginning to the end of anesthesia
Time frame: At the end of anesthesia
Length of surgery
From beginning to the end of surgery
Time frame: At the end of surgery
Postoperative hospitalization
Days of hospital staying after surgery
Time frame: During hospital
QoR-15
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.
Time frame: At 24 hours after surgery
The usage of rescue antiemetic drugs
Total usage of rescue antiemetic drugs after surgery
Time frame: Within 24 hours after surgery in anesthesia resuscitation unit
Adverse events
Any adverse events after surgery within postoperative 3 months
Time frame: Within 3 months after surgery
BMI
Body mass index
Time frame: Before surgery and at the postoperative 3 months
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI) will be assessed the quality of sleep. The higher score means the lower quality of sleep.
Time frame: Before surgery and at the 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 the postoperative 3 months
Hamilton Depression Rating Scale
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.
Time frame: Before surgery and at the postoperative 3 months
Hamilton Anxiety Rating Scale
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.
Time frame: Before surgery and at the postoperative 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.