Osellidine is Used for Analgesia During Daytime Hysteroscopic Surgery

February 19, 2026 updated by: Feng Gao, Tongji Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Intraoperative period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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)
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).
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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