Gynecological Day Surgery
Conditions
Brief summary
While providing equivalent analgesic efficacy, oxelidine significantly reduces the risk of adverse reactions-including respiratory depression, gastrointestinal dysfunction, and cognitive impairment-and facilitates faster recovery of postoperative cognitive orientation. It thus aligns with the core goals of "precise analgesia and rapid recovery" in daytime anesthesia and has been widely adopted in clinical practice. Given the high heterogeneity among day surgery patients (e.g., age, comorbidities, and surgical complexity), real-world studies can better capture a drug's performance across diverse populations. Therefore, this study will use a prospective, observational, real-world design to systematically compare the effects of oxelidine and traditional analgesic regimens in patients undergoing daytime hysteroscopic surgery.
Interventions
DRUGOxelidine
During anesthesia induction, a single dose of oxelidine at 0.03 mg/kg (or 2 mg) and flurbiprofen axetil 50 mg is administered. If analgesia is insufficient, oxelidine should be supplemented.
DRUGSufentanil or Remifentanil
Participants in the control group received traditional opioids for intraoperative analgesia. The choice of opioid (sufentanil single-dose or remifentanil infusion) and dosing regimen was determined by the attending anesthesiologist based on individual patient needs and clinical practice.
Sponsors
Tongji Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years. * Scheduled to undergo gynecological hysteroscopic surgery under general anesthesia with laryngeal mask airway (LMA). * Willing and able to provide written informed consent.
Exclusion criteria
* Incomplete medical records or data. * Severe hepatic or renal dysfunction. * Concurrent use of other potent analgesics (e.g., opioids, NSAIDs) or medications that may interfere with study outcomes. * Participation in another clinical trial within the past 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Intraoperative Adverse Events | Intraoperative period | he incidence of predefined intraoperative adverse events, including but not limited to: Hypotension: blood pressure decreased by more than 20% of the baseline value Hypertension: blood pressure increased by more than 20% of the baseline value Bradycardia: heart rate decreased by more than 20% of the baseline value Tachycardia: blood pressure increased by more than 20% of the baseline value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score (Visual Analog Scale, VAS) | immediately upon emergence from anesthesia, at the time of discharge from the Post-Anesthesia Care Unit (PACU), and at 24 hours postoperatively | VAS for pain is a validated, subjective measure of pain intensity. Patients self-report their pain by marking a point on a 100-mm horizontal line, anchored by "no pain" (0) and "worst pain imaginable" (100). The score is the distance in millimeters from the zero point, with a higher score indicating greater pain intensity |
| Postoperative recovery quality（Quality of Recovery-15 score, QoR-15） | 24 hours after the operation | QoR-15 score is a validated patient-reported outcome measure assessing the quality of postoperative recovery. It comprises 15 items with a total score ranging from 0 (extremely poor recovery) to 150 (excellent recovery), where a higher score indicates better recovery across domains such as physical comfort, emotional state, and physical independence. |
| Sleep Quality (Richards-Campbell Sleep Questionnaire, RCSQ) | Assessed at 24 hours postoperatively, referring to the sleep quality of the first postoperative night | The RCSQ is a validated, brief instrument specifically designed to assess nighttime sleep quality in hospitalized patients. It consists of five 100-mm visual analog scales measuring sleep depth, sleep latency, awakenings, ease of returning to sleep, and overall sleep quality. The mean score ranges from 0 (poorest sleep) to 100 (best sleep). |
| Incidence of Postoperative Adverse Events | 24 hours postoperatively | Postoperative adverse events include but is not limited to: postoperative nausea and vomiting (PONV), pruritus, dizziness, sedation, and respiratory depression. Each event will be recorded as present or absent based on patient report and clinical assessment. |
Outcome results
None listed