Postoperative nausea and vomiting (PONV)
Conditions
Interventions
Anrekefen Intervention Group:Based on the actual weight measured within 24 hours before the operation, calculate 1.0 µg/kg, without using ideal weight or corrected weight
no additional dose ceiling without evidence is set within the BMI range of 18 to 35 kg/m^2. Dilute 10 times, that is, the final volume is 0.10 mL/kg. Administer intravenously using an injection pump f
Normal Saline Placebo Control Group:Calculate the final volume according to the same weight rule and administer an equal volume of 0.9% sodium chloride injection.
Sponsors
Chaohu Hospital Affiliated to Anhui Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged 18-65 years. 2. ASA physical status I-III; for ASA III, the condition must be stable. 3. BMI 18-35 kg/m^2. 4. Scheduled to undergo elective benign conventional multi-port laparoscopic total hysterectomy or laparoscopic myomectomy under general anesthesia, with an estimated surgical duration of 60-240 minutes. 5. Apfel score 3-4. 6. Expected postoperative hospital stay and ability to safely use PCIA for at least 48 hours. 7. Able to understand and complete the pain NRS, nausea NRS, and the validated Chinese version of the QoR-15, and able to understand the use of PCIA. 8. Voluntary participation and signing of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Planned to undergo radical/staging surgery for malignancy, lymphadenectomy, omentectomy, intestinal or urinary tract resection and reconstruction, extensive resection for deep infiltrating endometriosis, or anticipated extensive adhesiolysis. 2. Long-term preoperative use of opioids, or regular use of analgesics within 2 weeks before surgery; except for occasional single use judged by the investigator not to affect the outcome, but must be documented. 3. Pre-existing chronic pelvic pain, chronic abdominal pain, or other chronic pain with resting or activity NRS >=4. 4. Nausea NRS >=4, vomiting, or retching within 24 hours before surgery, or use of antiemetics. 5. Allergy to anruikefen, sufentanil, acetaminophen, flurbiprofen axetil, dexamethasone, ondansetron, metoclopramide, droperidol, neostigmine, atropine, or any excipients of these formulations. 6. Active peptic ulcer or bleeding, aspirin-induced asthma or NSAID-induced hypersensitivity/bronchospasm, significant bleeding tendency, platelet count 3 times the upper limit of normal with the investigator's opinion that acetaminophen should not be used. 9. Preoperative QTcF >=480 ms, known long QT syndrome, severe arrhythmia, uncorrected hypokalemia (K <3.5 mmol/L), Parkinson's disease, history of severe extrapyramidal reactions, or judged by the investigator as unsuitable for the protocol-specified antiemetics. 10. Decompensated heart failure, uncontrolled severe hypertension, recent myocardial infarction/stroke, or other severe cardiopulmonary diseases. 11. Pregnancy, possible pregnancy, or breastfeeding. 12. Psychiatric disorders, cognitive impairment, language/communication barriers, or other conditions that prevent reliable completion of the questionnaires. 13. Currently participating in another interventional clinical study, or judged by the investigator as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative nausea and/or vomiting (PONV) incidence within 0–24 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically significant PONV within 0–24 h;Complete PONV response rate 0–24h;Rescue antiemetic use within 0–24 h;Total sufentanil consumption of PCIA 0–24 h;Quality of Recovery-15 score at 24 hours;Adverse events / Serious adverse events; | — |
Countries
China
Contacts
Public ContactYu Yongbo
Chaohu Hospital Affiliated to Anhui Medical University
Outcome results
None listed