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Remimazolam Tosylate Combined with Remifentanil for Painless Bronchoscopy in Children: A Randomized Controlled Clinical Trial

Remimazolam Tosylate Combined with Remifentanil for Painless Bronchoscopy in Children: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105332
Enrollment
Unknown
Registered
2025-07-02
Start date
2025-07-15
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Painless bronchoscopy in children

Interventions

Trial Group :Remazolam combined with remifentanil was used for anesthesia
Control group:Propofol combined with remifentanil was used for anesthesia

Sponsors

Boai Hospital of Zhongshan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Age 0~12 years old, gender is not limited; 2. Patients undergoing elective general anesthesia; 3. BMI 18.5~24.9kg/m^2;The child's weight is within two standard deviations of body weight (±2SD) in this age group; 4. ASA Class I or II; Mallampati Class I or II; 5. No contraindications to the use of esketamine, remimazolam, lidocaine, propofol, remifentanil and other drugs; 6. No history of drug abuse.

Exclusion criteria

Exclusion criteria: 1. Children whose parents or guardians do not agree to participate in the study; 2. BMI>=25kg/m^2 or the child's weight exceeds two standard deviations of body weight (±2SD) for the age group; 3. Children with severe heart, liver, kidney and other important organ dysfunction or disease; 4. Children with severe intracranial hypertension, intracranial infection, and intracranial mass lesions; 5. Children with congestive heart failure, shock, respiratory failure or electrolyte disorders; 6. Children with severe mental illness or neurological disease have a history of drug allergy; 7. Severe anemia, coagulation dysfunction, etc.; 8. Children with drug allergies; 9. Children who urgently need emergency surgical treatment.

Design outcomes

Primary

MeasureTime frame
Incidence of hypoxemia (SPO2 < 90%);

Secondary

MeasureTime frame
Success rate of bronchoscopy;Incidence of hypotension;Occurrence of adverse reactions;

Countries

China

Contacts

Public ContactMeiyun Tan

Department of Anesthsiology, Affiliated Boai Hospital of Zhongshan

13726028414@163.com+86 137 2602 8414

Outcome results

None listed

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