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NCT06172140
Efficacy and Safety of Ciprofol for the Sedation in Patients Undergoing Hysteroscopy
NA trial testing Ciprofol group in Ciprofol in 124 participants. Completed in 30 April 2024.
30 April 2024
Quick facts
| Lead sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 124 |
| Start date | 1 January 2024 |
| Primary completion | 30 April 2024 |
| Estimated completion | 30 April 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Ciprofol group
- Propofol group
Conditions studied
- Ciprofol — all drugs for Ciprofol →
- Hysteroscopy — all drugs for Hysteroscopy →
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Who can join
Adults 18 to 65, female only, with Ciprofol or Hysteroscopy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Eligible patients undergoing hysteroscopy were randomly assigned in a 1:1 ratio to receive intravenous anesthesia with either propofol (2 mg/kg) or remifentanil (0.4 mg/kg).Continuous monitoring of pulse oximetry (SpO2), blood pressure (BP), heart rate (HR), expired gas partial pressure of carbon dioxide, integrated respiratory index (IPI), tidal volume (TV), respiratory rate (RR), and minute ventilation (MV) was performed.During induction, the MOAA/S score was assessed every 30 seconds. If the MOAA/S score remained \>1, a supplementary dose of 1/2 of the initial dose was injected within 10 seconds.If more than 5 supplementary doses were required within 15 minutes, it was considered that the painless hysteroscopy failed and propofol was used to enhance sedation.Continuous oxygen administration at a flow rate of 5 liters per minute was provided through nasal catheters until the patient was fully alert with a MOAA/S score of 5 and vital signs were stable.Observation indicators included: (1) the success rate of hysteroscopy;(2) induction time (MOAA/S ≤ 1 after the first dose);(3) full recovery time of consciousness;(4) operation duration;(5) number of additional anesthetics;(6) incidence of hypotension, hypoxemia, sinus bradycardia, delayed recovery, and injection pain;(7) respiratory parameters and minimum SpO2, IPI values before anesthesia, after induction, and after awakening.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy and safety of ciprofol for sedation/anesthesia in patients undergoing hysteroscopy: a prospective, randomized, non-inferiority trial.
Cheng S, Wu H, Liu Z, Liu D, et al · · 2025 · cited 2× · PMID 40530830 · DOI 10.1080/07853890.2025.2517820
Verify or expand the search:
- PubMed search for NCT06172140
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ciprofol group
Trials testing the same drug.
- NCT07268872 — Dynamic Effects of Different Anesthetic Agents on the Immune Function of Healthy Volunteers · NA · enrolling by invitation
- NCT06952608 — Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors · Phase 4 · recruiting
- NCT06882980 — Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy · NA · recruiting
Other recruiting trials for Ciprofol
Currently open trials in the same condition.
- NCT06952608 — Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors · Phase 4 · recruiting
- NCT06882980 — Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy · NA · recruiting
Other Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials
Trials by the same sponsor.
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- NCT07533526 — Effects of Instrument-Assisted Constant-Speed Injection Versus Manual Injection on Pain From Large-Volume Subcutaneous I · NA · not yet recruiting
- NCT07408648 — A Clinical Study on the Efficacy and Safety of Hetrombopag in the Treatment of Thrombocytopenia Induced by Gynecological · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06172140 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Last refreshed: 21 August 2024
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing