Postoperative nausea and vomiting following general anesthesia
Conditions
Interventions
Experimental group: Oliceridine + Ondansetron (O group) :Prior to this trial, ED50 and ED95 studies of olanzapine for hysteroscopic surgery were conducted. Subsequently, groups were randomized using a
Control group: Sufentanil + Ondansetron (S group):The control group (Group S) received intravenous administration of 0.1 µg/kg sufentanil and 4 mg ondansetron after entering the operating room and com
Sponsors
Wang Chenggang(Study sponsor)
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–65 years; 2.ASA classification I–II; Body mass index (BMI) 18–30 kg/m^2; 3.Mallampati classification I–II; Electrocardiogram QTc interval <460 ms; 4.No contraindications to medication (uncontrolled blood pressure high/low blood pressure, bradycardia, thyroid function decreased, concomitant use of potent CYP3A4 inhibitors or benzodiazepines)
Exclusion criteria
Exclusion criteria: 1.Electrolyte imbalance (blood potassium 5.5 mmol/L); 2.History of cardiovascular disorder (coronary heart disease, heart failure, cardiac arrhythmia); 3.Hepatic or renal insufficiency (ALT/AST >2 times the upper limit, eGFR = grade 3, Child-Pugh class B/C); Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of nausea and vomiting within 24 hours postoperatively;QTc interval variation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of PONV within 0-6 hours postoperatively;Time of initial request for antiemetic medication;The proportion of patients experiencing clinically significant QTc prolongation (greater than 30 ms from baseline);Incidence of intraoperative adverse events (including blood pressure fluctuations exceeding 20% from baseline, oxygen saturation below 95%, intraoperative awareness, and intraoperative movement);Incidence of other opioid-related adverse reactions (including constipation, dry mouth, drowsiness, pruritus, urinary retention) following surgery;Oliceridine characteristic EEG spectrum;EEG spectrum analysis of oxazepam combined with propofol;Intraoperative vital signs (including blood pressure, oxygen saturation, Ai index, respiratory rate, etc.);Quality of Recovery-40 Scale (QoR-40);Intraoperative parameters (fluid volume, oliceridine dosage, sufentanil dosage, propofol dosage, operative time);NRS pain score preoperatively and upon discharge from PACU; | — |
Countries
China
Contacts
Public ContactWang Chenggang
Shanxi Provincial Hospital of Traditional Chinese Medicine / Shanxi Provincial Institute of Traditional Chinese Medicine
Outcome results
None listed