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Safety and efficacy of remimazolam compared with dexmedetomidine for sedation in patients with end-stage renal disease

Safety and efficacy of remimazolam compared with dexmedetomidine for sedation in patients with end-stage renal disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075278
Enrollment
Unknown
Registered
2023-08-31
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

end-stage renal disease

Interventions

Remimazolam group:sedated with remimazolam and maintained until the end of surgery
Dexmedetomidine group:sedated with dexmedetomidine and maintained until the end of surgery

Sponsors

Department of Anesthesiology, West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. age older than 18 years 2. ASA physical status score of III or IV 3. Patients with end-stage renal disease undergoing peritoneal dialysis tube placement or removal 4. signed the informed consent form

Exclusion criteria

Exclusion criteria: 1. Severe arrhythmia, such as HR=50 bpm at rest, third-degree atrioventricular block, frequent ventricular premature beat, QTc: male=450 ms, female=470 ms 2. Acute heart failure, unstable angina pectoris, myocardial infarction in the last 6 months, current heart failure (NYHA Classes III and IV) or severe valvular heart disease 3. uncontrolled hypertension with antihypertensive drugs [systolic blood pressure (SBP) = 160 mmHg when sitting and/or diastolic blood pressure (DBP) = 100 mmHg when sitting], SBP = 90 mmHg when sitting 4. Existing mental illness, taking psychotropic drugs for a long time, or cognitive dysfunction 5. Known contraindication to benzodiazepines or dexmedetomidine 6. Pregnant or lactating women 7. Other circumstances deemed by the researchers as inappropriate to participate in this study

Design outcomes

Primary

MeasureTime frame
Sedation success rate;

Secondary

MeasureTime frame
time of onset of sedation;number and rate of body movement during operation;duration of Anesthesia maintained a BIS value of 80;recovery time;rate of bradycardia;rate of hypotention;rate of hyoxemia;PONV;pain score;

Countries

China

Contacts

Public ContactLiang Peng

Department of Anesthesiology, West China Hospital of Sichuan University

liangpeng_world@foxmail.com+86 189 8060 2201

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026