Postoperative nausea and vomiting after high-risk laparoscopic surgery
Conditions
Interventions
Experimental group:Amisulpride 5mg + True Transcutaneous Acupoint Electrical Stimulation + Placebo Injection.
Positive control group:Amisulpride 5mg + sham TEAS stimulation + Ondansetron 4mg
Control group:Amisulpride 5mg + sham TEAS stimulation + placebo injection
Sponsors
Hefei Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. American Society of Anesthesiologists (ASA) physical condition classification: Grade I - III; 2. Age 18 to 60 years old, gender not restricted; 3. Body Mass Index (BMI) between 18.0 - 30.0 kg/m^2 (including the critical value); 4. Scheduled for elective laparoscopic surgery requiring general anesthesia; 5. Judged as patients at moderate to high risk of postoperative nausea and vomiting (score >= 2) based on the Apfel simplified risk score; 6. Able to understand the procedures and methods of this experiment, having given full informed consent, and voluntarily participating and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Has a history of severe respiratory system diseases; 2. Central nervous system disorders: Subjects with epilepsy, Parkinson's disease, or other central nervous system disorders causing nausea and vomiting; 3. Cardiovascular system disorders: Subjects with NYHA cardiac function grade III-IV within 6 months prior to screening, unstable angina pectoris, acute myocardial infarction, or poorly controlled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg) or other heart diseases; 4. Digestive system disorders: Subjects with intestinal obstruction or other digestive system disorders causing nausea and vomiting; 5. Subjects with obvious and chronic dizziness history, nausea and/or vomiting within 24 hours before the operation, use of antiemetic drugs, emetic drugs, opioid drugs, etc. within 3 days before the operation; 6. Those who are known to be allergic to amisulpride, ondansetron, or any excipient or any component used in this experiment, or have a history of allergic reaction; 7. Patients with implanted cardiac pacemaker, cardioverter-defibrillator, or defibrillator; 8. Subjects with skin problems in the acupoint stimulation area.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of postoperative nausea and vomiting within 24 hours after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time and usage rate of antiemetic drugs administered within 48 hours after the surgery;Visual Analogue Scale; | — |
Countries
China
Contacts
Public ContactXin Wang
Hefei Second People's Hospital
Outcome results
None listed