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Comparison analysis of the effects of Sufentanil and Fentanyl on incidence of delirium in the surgical intensive care units: A Randomized, Prospective Multicenter study

Comparison analysis of the effects of Sufentanil and Fentanyl on incidence of delirium in the surgical intensive care units: A Randomized, Prospective Multicenter study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011623
Enrollment
402
Registered
2026-02-19
Start date
2024-01-09
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

None listed

Interventions

Drug : This study is a randomized, double-blind, multicenter, parallel-group clinical trial comparing two opioid-based analgesic strategies in adult patients requiring mechanical ventilation in surgic

Sponsors

Keimyung University Dongsan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients aged 18 years or older Patients admitted to a surgical intensive care unit requiring mechanical ventilation Patients requiring opioid-based analgesia for sedation management Written informed consent obtained from the patient or a legally authorized representative

Exclusion criteria

Exclusion criteria: Known hypersensitivity or contraindication to sufentanil or fentanyl Severe neurologic conditions precluding reliable delirium assessment (e.g., persistent coma, severe brain injury) Presence of delirium at baseline prior to randomization Pregnancy or breastfeeding Any condition judged by the investigator to make participation inappropriate

Design outcomes

Primary

MeasureTime frame
Incidence of delirium during ICU stay. Delirium is assessed using the Confusion Assessment Method for the ICU (CAM-ICU). Delirium occurrence is defined as at least one positive CAM-ICU assessment during the ICU stay.

Secondary

MeasureTime frame
Duration of delirium during ICU stay, defined as the total number of days with a positive CAM-ICU assessment.

Countries

Korea, Republic of

Contacts

Public ContactChanhee Park

Keimyung University Dongsan Hospital

domissionary@naver.com+82-53-258-6152

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Mar 14, 2026