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A study comparing the safety and efficacy of remimazolam tosilate , propofol, midazolam and dexmedetomidine in RICU elderly patients undergoing tracheoscope

A study comparing the safety and efficacy of remimazolam tosilate , propofol, midazolam and dexmedetomidine in RICU elderly patients undergoing tracheoscope

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048547
Enrollment
Unknown
Registered
2021-07-10
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

Xuyào xíng xian zhi jìng jianchá de xiangguan jíbìng 13 / 5000 ???? Related diseases that require bronchoscopy

Interventions

Experimental group1:Remazolam tosylate 0.1mg/kg was given before bronchoscopy, the administration process was completed within 30 seconds, and fentanyl 4ug/kg was continued to be given
Experimental group2:Give midazolam 0.03mg/kg before bronchoscopy and finish the administration within 30 seconds, continue to give fentanyl 4ug/kg
Experimental group3:Before bronchoscopy, give propofol 0.5mg/kg, the administration process is completed within 30 seconds, continue to give fentanyl 4ug/kg
Experimental group4:Give dexmedetomidine 0.5ug/kg before bronchoscopy and finish the administration within 30 seconds, continue to give fentanyl 4ug/kg
Control group:Give fentanyl 4ug/kg before bronchoscopy

Sponsors

Xinxiang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged 65 to 100 years; 2. The comprehensive assessment showed that it was in line with the indications for sedation, and the anesthesia risk assessment was at level II to IV; 3. RICU patients who need to undergo bronchoscopy, and obtain the informed consent of the patient or their family members.

Exclusion criteria

Exclusion criteria: 1.Severe bradycardia (heart rate <55 beats/min) or suffering from II-III degree heart block (except for a pacemaker); 2.Hearing or vision loss, or any other conditions that may seriously interfere with the collection of research data; 3.Have a history of long-term use of benzodiazepines or opioids; 4.A person with a known history of allergies to any study drug, a history of allergic diseases, and a person with lipometabolism; a person with a previous mental illness; 5.Patients are unlikely to require continuous sedation during mechanical ventilation (such as Guillain-Barré syndrome); 6.Clinicians judge patients who are unlikely to be separated from mechanical ventilation, such as diseases/injuries that mainly affect the neuromuscular function of the ventilator and obvious irreversible diseases that require long-term ventilation support (such as high spinal cord injury) 7.Those who died or were dying within 24 hours of treatment; 8.Participate in other clinical research; 9.The researcher believes that it is not suitable to participate in this clinical research.

Design outcomes

Primary

MeasureTime frame
The modified alertness/sedation score immediately after administration, the time from the start of induction to the modified alertness/sedation score less than 3 points, and the time to recover to 5 points;Hemodynamic parameters;

Countries

China

Contacts

Public ContactLiu Dezhi

Xinxiang Central Hospital

doctorldz@163.com+86 15637359781

Outcome results

None listed

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