Osellidine is Used for Analgesia During Daytime Hysteroscopic Surgery

Feasibility Study on the Use of Osellidine for Perioperative Analgesia in 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gynecological Day Surgery
• Intervention / Treatment: Drug: Oxelidine; Drug: Sufentanil or Remifentanil

• Study Type: Observational
• Enrollment (Estimated): 310

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Oxelidine Group; Patients who received oxelidine and NSAIDS during anesthesia induction and maintain without other opioid drugs	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.
Control Group; Patients who receive traditional opioid drugs during anesthesia induction and maintain, such as afentanil, sufentanil, and remifentanil	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score (Visual Analog Scale, VAS)	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	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）	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.	24 hours after the operation
Sleep Quality (Richards-Campbell Sleep Questionnaire, RCSQ)	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).	Assessed at 24 hours postoperatively, referring to the sleep quality of the first postoperative night
Incidence of Postoperative Adverse Events	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.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: January 31, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acids, Acyclic; Carboxylic Acids; Piperidines; Propionates; Fentanyl; Remifentanil; Sufentanil
• Other Study ID Numbers: 2025S099

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No