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90% Effective Dose of Oliceridine in Combination with Propofol or Remimazolam for Hysteroscopy and Its Effect Comparison

Oliceridine Combined with Propofol or Remimazolam for Hysteroscopy: A Randomized, Biased-Coin Up-and-Down Sequential Dose-Finding Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093189
Enrollment
Unknown
Registered
2024-11-29
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Pain

Interventions

Oliceridine combined with propofol:Oliceridine is administered intravenously before the surgery, followed by 2 mg/kg of propofol.
Oliceridine combined with Remimazolam:Oliceridine is administered intravenously before the surgery, followed by 0.25 mg/kg of remimazolam.

Sponsors

Women's Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participates in the study and signs the informed consent form, with the ability to adhere to the study protocol and requirements. 2. Aged 18 to 55 years. 3. Body mass index (BMI) between 18 and 25 kg/m2 (inclusive). 4. In a resting state, systolic blood pressure between 90 and 140 mmHg, diastolic blood pressure between 50 and 90 mmHg, heart rate between 50 and 100 beats per minute, and SpO2 > 95% under indoor conditions. 5. American Society of Anesthesiologists (ASA) physical status I or II, with no contraindications to intravenous anesthesia, and diagnosed by a gynecologist as needing hysteroscopic examination.

Exclusion criteria

Exclusion criteria: 1. Clinical history or physical examination indicating the presence of significant medical conditions (other than the study indications). 2. Significant abnormalities in vital signs or clinical laboratory test results. 3. Known allergy to any study drug. 4. Active gastrointestinal, respiratory, circulatory, neurological, or psychiatric conditions within 35 days prior to screening, deemed clinically significant by the investigator. 5. Clinically significant ECG abnormalities at screening, including QTcF >= 470 ms (female patients) on a 12-lead ECG.

Design outcomes

Primary

MeasureTime frame
The ED90 of oliceridine for suppressing response to cervical dilation;

Secondary

MeasureTime frame
Sedative drug total dosage;Anesthesia induction time;Maintenance time of first dose;Times of body movement;Length of PACU stay;Time to full alertness;Procedure duration;Endoscopist satisfaction;Patient satisfaction;total sedation time;Pain score at the time of PACU discharge;

Countries

China

Contacts

Public ContactYao Zhang

Women's Hospital of Nanjing Medical University

yaozhang@njmu.edu.cn+86 187 6185 3348

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026