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Not Yet RecruitingNCT07409311

Osellidine is Used for Analgesia During Daytime Hysteroscopic Surgery

Feasibility Study on the Use of Osellidine for Perioperative Analgesia in Daytime Hysteroscopic Surgery

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
310 (estimated)
Sponsor
Tongji Hospital · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGOxelidineDuring 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 RemifentanilParticipants 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.

Timeline

Start date
2026-02-10
Primary completion
2027-12-31
Completion
2028-02-01
First posted
2026-02-13
Last updated
2026-02-23

Source: ClinicalTrials.gov record NCT07409311. Inclusion in this directory is not an endorsement.