Gynecological Day SurgeryNCT07409311
Osellidine is Used for Analgesia During Daytime Hysteroscopic Surgery
An observational study of Gynecological Day Surgery, run by Tongji Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Day Surgery
- What is being tested?
- Oxelidine and Sufentanil or Remifentanil
- Type of treatment
- Injection or infusion
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2026to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients (age >18 years) scheduled for gynecological hysteroscopic surgery under LMA general anesthesia at a single center.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Gynecological Day Surgery
- Being tested
- Oxelidine, Sufentanil or Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxelidineDrug
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 RemifentanilDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oxelidine Group | Patients who received oxelidine and NSAIDS during anesthesia induction and maintain without other opioid drugs Receives: Drug: Oxelidine | |
| Control Group | Patients who receive traditional opioid drugs during anesthesia induction and maintain, such as afentanil, sufentanil, and remifentanil Receives: Drug: Sufentanil or Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Intraoperative period
Secondary outcomes (4)
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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start10 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological Day SurgeryStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409311
- Sponsor's protocol ID
- 2025S099
- Status last verified
- Feb 2026
- First submitted
- 31 Jan 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on the Use of Osellidine for Perioperative Analgesia in Daytime Hysteroscopic Surgery
- ClinicalTrials.gov ID
- NCT07409311
- Acronym / sponsor ID
- 2025S099
- Conditions
- Gynecological Day Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxelidine Group | – | Drug: OxelidinePatients who received oxelidine and NSAIDS during anesthesia induction and maintain without other opioid drugs |
| Control Group | – | Drug: Sufentanil or RemifentanilPatients who receive traditional opioid drugs during anesthesia induction and maintain, such as afentanil, sufentanil, and remifentanil |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients (age >18 years) scheduled for gynecological hysteroscopic surgery under LMA general anesthesia at a single center.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxelidineDuring 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. | Drug | Oxelidine Group |
| Sufentanil 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. | Drug | Control Group |
Primary outcome
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
4 secondary outcomes
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
Postoperative recovery quality（Quality of Recovery-15 score, QoR-15）
Time frame: 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
Incidence of Postoperative Adverse Events
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecological Day Surgery, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Intraoperative Adverse Events (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.