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Efficacy and Safety of Oliceridine Combined with Remimazolam for Fiberoptic Bronchoscopy

Efficacy and Safety of Oliceridine Combined with Remimazolam for Fiberoptic Bronchoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110217
Enrollment
Unknown
Registered
2025-10-10
Start date
2025-10-12
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Painless Bronchoscopy Examination

Interventions

The group of sufentanil 0.1µg/kg:Administer 0.1 µg/kg sufentanil hydrochloride combined with 0.3 mg/kg remimazolam for induction
The group of oliceridine 20µg/kg:Administer 20 µg/kg oliceridine combined with 0.3 mg/kg remimazolam for induction
The group of oliceridine 40µg/kg:Administer 40 µg/kg oliceridine combined with 0.3 mg/kg remimazolam for induction

Sponsors

Gansu Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists (ASA) classification level I-III; 2. Age: 18-80 years old; 3. 18 kg/m^2 < BMI < 30 kg/m^2; 4. Patients undergoing painless bronchoscopy: indications include pneumonia, bronchiectasis, pulmonary shadow, hemoptysis, and others; 5. Consent to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe sleep apnea syndrome (apnea-hypopnea index > 40) or previous hypoxemia symptoms (SpO2 < 90% when breathing room air or SpO2 <= 94% when receiving 2 L/min oxygen via nasal cannula); 2. Patients with a history of alcohol abuse or currently using any psychoactive drugs; 3. Patients with neurological disorders or other conditions that make it difficult to assess consciousness response; 4. ECG findings indicating abnormal QT interval; 5. Known allergies to opioids, benzodiazepines, or their components (soy/egg products) or has contraindications for their use; 6. Patients with severe liver and kidney dysfunction and/or coagulopathy; 7. Patients with poorly controlled cardiovascular or respiratory diseases, such as acute coronary syndrome, severe hypertension, arrhythmia, heart failure, severe chronic obstructive pulmonary disease, and acute asthma; 8. Predictable difficult airway (restricted mouth opening, limited neck and jaw movement, ankylosing spondylitis, temporomandibular joint disorders, partial tracheal stenosis, a modified Mallampati score greater than class III); 9. Participated as a subject in other drug clinical trials within the last 3 months.

Design outcomes

Primary

MeasureTime frame
Success Rate of Bronchoscopic Diagnosis and Treatment;

Secondary

MeasureTime frame
Hemodynamic Indicators;Cough Score (Visual Analog Scale, VAS) Score;Anesthetic effect and recovery quality;The dosage of sedatives and analgesics used for preoperative induction and the final cumulative dosage used during surgery;Incidence of adverse events;Minimum SpO2;Intraoperative coughing and body movement;Number of interruptions during endoscopic treatment;Satisfaction scores of anesthesiologists, bronchoscopists and patients;

Countries

China

Contacts

Public ContactWenjun Yan

Gansu Provincial People's Hospital

15130961161@163.com+86 138 9337 0700

Outcome results

None listed

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