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A multicenter randomized controlled study on the combined target-controlled infusion of remifentanil and propofol for hysteroscopic diagnosis and treatment

A multicenter randomized controlled study on the combined target-controlled infusion of remifentanil and propofol for hysteroscopic diagnosis and treatment

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118685
Enrollment
Unknown
Registered
2026-02-10
Start date
2026-02-10
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia with intravenous anesthesia.

Interventions

Group O:Intravenous injection of 0.03mg/kg of oxypertine
Group S:Sufentanil 0.15 µg/kg, intravenous injection

Sponsors

Yantai Affiliated Hospital of Binzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years; 2. ASA class I-III; 3. Ability to comprehend and voluntarily provide informed consent (signed by participant or legal guardian).

Exclusion criteria

Exclusion criteria: 1. Presence of clear symptoms or signs of respiratory tract infection within the last two weeks. 2. Room air oxygen saturation (SpO2) 1 hour. 4. Coagulation dysfunction or platelet count = 450 ms (corrected by Fridericia's formula), or exercise tolerance < 4 METs. 6. History of postoperative nausea and vomiting (PONV). 7. Known allergy to eggs, soy products, opioids, opioid antagonists, propofol, or related agents. 8. Participation in another drug clinical trial as a subject within the past 3 months. 9. History or presence of conditions such as traumatic brain injury, potential for seizures, myoclonus, intracranial hypertension, cerebral aneurysm, or cerebrovascular accident. 10. History of psychiatric or neurological disorders, including schizophrenia, intellectual disability, mania, psychosis, long-term use of psychotropic medications, opioid abuse, alcohol abuse (specified by duration and quantity), or cognitive dysfunction. 11. Emergency surgery. 12. Pregnancy or lactation. 13. Foreseen difficult airway or planned tracheal intubation or laryngeal mask airway use. 14.Patients considered by the investigator to be hemodynamically unstable, at high risk of reflux and aspiration, or otherwise unsuitable for participation in this clinical study.

Design outcomes

Primary

MeasureTime frame
The incidence of hypoxia (defined as 75% <= SpO2 <= 89%, lasting for <60 seconds) during hysteroscopic procedures.;

Secondary

MeasureTime frame
the lowest SpO2;Incidence of subclinical respiratory depression(90% 60 seconds) during hysteroscopy treatment.;Adverse events related to both anesthesia/sedation and opioid analgesia;

Countries

China

Contacts

Public ContactLi Wei

Yantai Affiliated Hospital of Binzhou Medical University

280417664@qq.com+86 535 4770531

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026