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Efficacy and safety of remimazolam tosylate for fibrobronchoscopy in elderly patients: a randomized, double-blind, control clinical study

Efficacy and safety of remimazolam tosylate for fibrobronchoscopy in elderly patients: a randomized, double-blind, control clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065438
Enrollment
Unknown
Registered
2022-11-04
Start date
2022-11-14
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

fibrobronchoscopy in elderly patients

Interventions

remimazolam group:Administration of intravenous remimazolam
propofol group:Administration of intravenous propofol

Sponsors

The Affiliated Hospital, Hengyang Medical School, University of South China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 60 years, both sexes; 2. The ASA classification is I-III; 3. 18 kg/m2 or less a BMI of 30 kg/m2 or less; 4. Subjects who plan to undergo bronchoscopic diagnosis and/or treatment without assisted ventilation; 5. 10 times/min = 93%; SBP 90 MMHG or higher; DBP 55 MMHG or higher; 50 beats/min <= heart rate <= 100 beats/min; 6. Able to understand and voluntarily sign the informed consent (ICF), willing to comply with and expected to complete the trial in accordance with the protocol.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications of deep sedation/general anesthesia or with a history of sedation/anesthesia accidents; 2. Parazepines, opioids, propofol, flumazenil, naloxone, lidocaine and other drugs and their drug components Sensitive or taboo; 3. Patients who have been intubated and/or mechanically ventilated before bronchoscopy; 4. Gastrointestinal history: history of gastrointestinal retention, active bleeding, gastroesophageal reflux or obstruction, and assessment of the risk of regurgitation and aspiration; 5. History of nervous system: craniocerebral injury, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; 6. Psychiatric history: patients with a history of schizophrenia, mania, psychosis, or cognitive dysfunction.

Design outcomes

Primary

MeasureTime frame
modified obsevers assessment of alertness/sedation scale (MOAA/S) assessment;Aldrete assessment;Blood Pressure;heart rate;respiratory rate;SpO2;

Secondary

MeasureTime frame
Start check time;End Check Time;remedies;Sufentanil and lidocaine use;remedies;

Countries

China

Contacts

Public ContactChengda Zhao

The Affiliated Hospital, Hengyang Medical School, University of South China

zcd880413@163.com+86 15115465573

Outcome results

None listed

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