NCT06848452

Clinical Study on the Efficacy and Safety of Hydromorphone for ICU Analgesia

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-center clinical study to evaluate the advantages, extensibility and safety of hydromorphone as an analgesic drug in ICU, and to compare it with remifentanil, a traditional sedative drug. These conclusions can guide us to understand the characteristics of analgesic drugs, carry out appropriate pain management, improve the status of ICU patients, and improve the quality of life of patients.

Detailed description

This study will be carried out in the Affiliated Hospital of Nantong University. It is expected that 300 ICU patients who received invasive mechanical ventilation and needed analgesia and sedation will be included. The RASS and CPOT scores of 300 patients after using hydromorphone or remifentanil were collected and stored in the clinical trial sample database to evaluate and record the relevant indicators of the subjects. The relevant medical records in clinical treatment were analyzed and studied. Each subject will be numbered and a separate medical record established. The purpose of this prospective single-center observational clinical study is to : 1 ) evaluate the advantages, extensibility and safety of hydromorphone as an ICU analgesic ; 2 ) Compared with the traditional sedative drug remifentanil. Including gastrointestinal dysfunction, respiratory depression, sedative use, mechanical ventilation time, ICU hospitalization time, extubation failure rate, etc.

Conditions

• Analgesia
• ICU Patients Requiring Invasive Mechanical Ventilation

Interventions

Type	Name	Description
OTHER	no-intervention	no-intervention

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-02-27
• Last updated: 2025-03-14

Locations

1 site across 1 country: China