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Efficacy and safety of remimazolam with alfentanil in bronchoscopy in adults: a randomized, double-blind, controlled clinical study

Efficacy and safety of remimazolam with alfentanil in bronchoscopy in adults: a randomized, double-blind, controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095562
Enrollment
Unknown
Registered
2025-01-08
Start date
2023-04-13
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Bronchial Diseases

Interventions

Group R-A:Rimazolam benzoate compounded with alfentanil
Group P-A:Propofol with alfentanil

Sponsors

Lishui People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients undergoing painless bronchoscopy in our hospital in 2023, aged 18 to 75 years, BMI 18.5 to 23.9 kg/m2 , ASA class I to II, complete electrocardiogram and various biochemical tests, no coagulation dysfunction, and patients or family members who were informed of the anesthetic use of this study and voluntarily signed the informed consent form to participate in this study were selected.

Exclusion criteria

Exclusion criteria: 1.Those with contraindications to conventional (bronchial) bronchoscopy, severe hepatic and renal dysfunction and hemostasis, as well as full stomach or gastrointestinal obstruction with gastric content retention. 2. Potentially life-threatening circulatory and respiratory diseases that are not properly controlled, such as acute coronary syndrome, uncontrolled severe hypertension, severe arrhythmias, severe heart failure, recent acute myocardial infarction, and acute attacks of asthma. 3.Patients with ASA class V. 4.Patients without accompanying or guardian. 5. Those with sedation/anesthesia drug allergy and other extremely high risk of anesthesia. 6.Allergy or contraindication to the subject drug. 7.Those who do not wish to participate in this study. Translated with www.DeepL.com/Translator (free version)

Design outcomes

Primary

MeasureTime frame
Incidence of hypoxemia;Excellent rate of anesthesia effect;

Secondary

MeasureTime frame
Wake-up time;Incidence of cough;Intraoperative stress reaction (blood pressure, heart rate fluctuation);Operating satisfaction of surgeons;Patient comfort score; dosage of remazolam or propofol ;

Countries

China

Contacts

Public ContactDai Hong

Lishui People's Hospital

946795481@qq.com+86 189 5709 1856

Outcome results

None listed

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