Osellidine is Used for Analgesia During Daytime Hysteroscopic Surgery

NCT07409311 | Not Yet Recruiting

• 1 other identifier: 2025S099
• Study Type: observational
• Target: 310
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gynecological Day Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of Intraoperative Adverse Events

  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

  Intraoperative period

Secondary Outcomes (4)

• 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

• Postoperative recovery quality（Quality of Recovery-15 score, QoR-15）

  24 hours after the operation

• Sleep Quality (Richards-Campbell Sleep Questionnaire, RCSQ)

  Assessed at 24 hours postoperatively, referring to the sleep quality of the first postoperative night

• Incidence of Postoperative Adverse Events

  24 hours postoperatively

Study Arms (2)

Oxelidine Group

Patients who received oxelidine and NSAIDS during anesthesia induction and maintain without other opioid drugs

Drug: Oxelidine

Control Group

Patients who receive traditional opioid drugs during anesthesia induction and maintain, such as afentanil, sufentanil, and remifentanil

Drug: Sufentanil or Remifentanil

Interventions

Oxelidine DRUG

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.

Oxelidine Group

Sufentanil or Remifentanil DRUG

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female patients (age \>18 years) scheduled for gynecological hysteroscopic surgery under LMA general anesthesia at a single center.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Interventions

Sufentanil; Remifentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 13, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02