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NCT Number: NCT07409311

Osellidine is Used for Analgesia During Daytime Hysteroscopic Surgery

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.

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Key information

Conditions

Gynecological Day Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of Intraoperative Adverse Events

    Time frame: 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 outcomes

  1. 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

    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

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

    Time frame: 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.

  3. Sleep Quality (Richards-Campbell Sleep Questionnaire, RCSQ)

    Time frame: 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).

  4. Incidence of Postoperative Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 13, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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