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Efficacy and safety of ciprofol and dexmedetomidine for agitation and delirium in ICU

Prospective, multicenter, randomized, single-blind, parallel controlled clinical study on the efficacy and safety of ciprofol and dexmedetomidine for agitation and delirium in ICU

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062799
Enrollment
Unknown
Registered
2022-08-19
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Delirium

Interventions

Ciprofol group:Intravenous ciprofol
Dexmedetomidine group:Intravenous dexmedetomidine

Sponsors

Dalian Municipal Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients with agitation or hyperactive delirium in ICU are expected to need sedation for 4-24 hours after randomization; 2. The expected sedation target should be within the range of RASS (-2 to +1); 3. Age 18 to 85 years old, without gender restrictions; 4. Body mass index (BMI) 18kg/m^2 to 30 kg/m^2; 5. The patient or his family members will fully understand the purpose and significance of the test, voluntarily participate in the ICU within 24 hours after admission and sign an informed consent form containing contact information.

Exclusion criteria

Exclusion criteria: 1. Patients with known hypersensitivity to eggs, soy products, ciprofol or dexmedetomidine, and those with contraindications to ciprofol, dexmedetomidine, opioids and their reliever; 2. Had received sedation treatment on other wards within 1 day before transfer to ICU; 3. History or evidence that patient is at increased risk during sedation / anesthesia during screening; 4. Advanced tumor; 5. Patients with a history of alcohol or drug abuse; 6. Pregnant and lactating women; 7. Received blood purification treatment during the use of ciprofol or dexmedetomidine (which may affect the pharmacokinetics and efficacy of ciprofol or dexmedetomidine); 8. Participation in other clinical trials within 1 month prior to screening; 9. Those in which efficacy and adverse effects could not be evaluated due to incomplete data and non-uniform evaluation criteria; 10. It was decided by the investigators for various reasons that patients would not be eligible for inclusion in the clinical trial.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;Short term mortality;

Secondary

MeasureTime frame
Additional medication rates;Number of recurrences of agitation within 24 hours;Proportion of patients intubated within 24 hours and using rescue medication;Doses and costs of analgesic and sedative medications;Length of ICU stay and cost of ICU stay;

Countries

China

Contacts

Public ContactSiBo Liu

Dalian Municipal Central Hospital

icu2000@163.com+86 411 84412001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026