Skip to content

A prospective, multicenter, non randomized, controlled trial for dexmedetomidine hydrochloride and butorphine in the analgesia and safety of ICU patients

A prospective, multicenter, non randomized, controlled trial for dexmedetomidine hydrochloride and butorphine in the analgesia and safety of ICU patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026378
Enrollment
Unknown
Registered
2019-10-05
Start date
2019-10-07
Completion date
Unknown
Last updated
2019-10-07

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

Conditions

Critical patient

Interventions

Experimental group:Give dexmedetomidine in combination with butorphanol
Control group:Give conventional analgesic sedation treatment

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. GCS score > 8 points; 2. CPOT score >=3 points and RASS score >=2 point; 3. Aged 18 to 75 years old; 4. Signing an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breastfeeding; 2. Severe, existing substantial liver disease with clinically significant portal hypertension, Child-Pugh C cirrhosis or acute liver failure; 3. Bronchial asthma or COPD, myasthenia gravis patients; 4. Patients with a history of alcohol or drug abuse; 5. Inability to obtain informed consent or authorization; 6. No sedative, analgesic treatment of patients; 7. GCS score <=8 points; 8. Heart rate <50 beats / min (II / III degree atrioventricular block, except for the installation of pacemaker), MAP <55mmHg; 9. Receive 2 or more sedative or analgesic drugs within 10 or 24 hours; 10. Patients who are allergic to dexmedetomidine or butorphanol.

Design outcomes

Primary

MeasureTime frame
RASS score, CPOT score;

Secondary

MeasureTime frame
Severe complication rate (respiratory depression, sputum, gastrointestinal dysfunction (new occurrence: intestinal obstruction / inhibition of bowel movement / constipation), hypotension, bradycardia);ICU total hospitalization expenses, hospitalization time, ICU hospitalization time, mechanical ventilation time, APACHE II score, SOFA score, delirium score;

Countries

China

Contacts

Public ContactTongwen Sun

The First Affiliated Hospital of Zhengzhou University

suntongwen@163.com+86 13838516916

Outcome results

None listed

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