Osellidine is Used for Analgesia During Daytime Hysteroscopic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxelidine, Sufentanil or Remifentanil.
- Who it may be relevant to
- Registry conditions: Gynecological Day Surgery. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility Study on the Use of Osellidine for Perioperative Analgesia in Daytime Hysteroscopic Surgery
Overview
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
- Drug Oxelidine
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. - Drug Sufentanil 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.
Primary outcome measures
- Incidence of Intraoperative Adverse Events [Time frame: Intraoperative period]
Secondary outcome measures (4)
- Pain Score (Visual Analog Scale, VAS) [Time frame: immediately upon emergence from anesthesia, at the time of discharge from the Post-Anesthesia Care Unit (PACU), and at 24 hours postoperatively]
- Postoperative recovery quality（Quality of Recovery-15 score, QoR-15） [Time frame: 24 hours after the operation]
- Sleep Quality (Richards-Campbell Sleep Questionnaire, RCSQ) [Time frame: Assessed at 24 hours postoperatively, referring to the sleep quality of the first postoperative night]
- Incidence of Postoperative Adverse Events [Time frame: 24 hours postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07409311 · 2025S099