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Safety and efficacy of remimazolam tosilate in bronchoscopy anesthesia: a randomized controlled trial

Safety and efficacy of remimazolam tosilate in bronchoscopy anesthesia: a randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053266
Enrollment
Unknown
Registered
2021-11-18
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Pulmonary disease

Interventions

Group 1:Remazolam for common bronchoscopy
Group 2:Propofol for general bronchoscopy
Group 3:Remazolam for complex bronchoscopy anesthesia
Group 4:Propofol for complex bronchoscopy anesthesia

Sponsors

National Cancer Center (Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years; 2. Patients who were scheduled to undergo bronchoscopy (divided into ordinary and complex endoscopic patients); 3. Agree to be tested and sign informed consent; 4. ASA I-III.

Exclusion criteria

Exclusion criteria: 1. A history of acute inflammation of the respiratory tract that has not been cured within one week; 2. Patients with severe respiratory diseases; 3. Mental disorder; 4. Difficulty in respiratory management (Mallampati grade IV); 5. Have a history of drug abuse; 6. Those who have used benzodiazepines continuously for more than 3 months; 7. BMI 31; 8. Liver and kidney insufficiency; 9. Heart insufficiency; 10. Those with contraindications to the drug application in the study; 11. Patients who have participated in other medical studies in the past month.

Design outcomes

Primary

MeasureTime frame
Incidence of hypoxemia;BPS(Behavioral Pain Scale) analgesia score;

Secondary

MeasureTime frame
Dosage of remazolam, fentanyl and propofol and times of addition;The nasal EtCO2;Respiratory rate;Awakening time;MOAA(modified observer's assessment of alert)/S Sedation and wakefulness score;

Countries

China

Contacts

Public ContactZheng Hui

National Cancer Center (National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College)

wulin1950@126.com+86 10 87788256

Outcome results

None listed

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