Clinical trial NCT05240482: ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting
Official title: Zusanli (ST36) Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting in Women Following Bariatric Surgery: A Single-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: postoperative nausea and vomiting
bariatric surgery
Zusanli (ST36)
anisodamine
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of PONV within the first 24 hours
timeFrame: At 0-24 hours after surgery
Secondary outcomes:
measure: Time to the first rescue antiemetics
timeFrame: At 0-24 hours after surgery
measure: The incidence and severity of PONV assessed at 2, 6, 48, and 72 hours after surgery
timeFrame: At 0-24 hours after surgery
measure: Early recovery outcomes
timeFrame: Before discharge
measure: Consumption of propofol
timeFrame: During the surgery
measure: Consumption of remifentanil
timeFrame: During the surgery
measure: Consumption of cisatracurium
timeFrame: During the surgery
measure: Consumption of dexmedetomidine
timeFrame: During the surgery
measure: Length of anesthesia
timeFrame: At the end of anesthesia
measure: Length of surgery
timeFrame: At the end of surgery
measure: Postoperative hospitalization
timeFrame: During hospital
measure: QoR-15
timeFrame: At 24 hours after surgery
measure: The usage of rescue antiemetic drugs
timeFrame: Within 24 hours after surgery in anesthesia resuscitation unit
measure: Adverse events
timeFrame: Within 3 months after surgery
measure: BMI
timeFrame: Before surgery and at the postoperative 3 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Before surgery and at the postoperative 3 months
measure: Gastrointestinal Symptom Rating Scale
timeFrame: Before surgery and at the postoperative 3 months
measure: Hamilton Depression Rating Scale
timeFrame: Before surgery and at the postoperative 3 months
measure: Hamilton Anxiety Rating Scale
timeFrame: Before surgery and at the postoperative 3 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Second Affiliated Hospital of Anhui Medical University
Study officials:
affiliation: The Second Hospital of Anhui Medical University
name: Ye Zhang, M.D.
role: STUDY_CHAIR
References: