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

Not yet recruiting

• Conditions: Analgesia; ICU Patients Requiring Invasive Mechanical Ventilation

• Registration Number: NCT06848452
• Lead Sponsor: Affiliated Hospital of Nantong University

Brief 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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-27
• Study Start: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age ≥18 years and ≤75 years;
• For patients requiring sedation and analgesia in ICU, invasive mechanical ventilation time is expected to be ≥24 hours;
• Obtain informed consent from patients or family members.

Exclusion Criteria

• Under 18 years of age, or over 75 years of age;
• pregnancy or breastfeeding;
• Known or suspected allergy to opioids (e.g., fentanyl, remifentanil, hydromorphone), butorphanol, midazolam.
• General anesthesia surgery within 48 hours;
• Acute bronchial asthma.
• Acute intestinal obstruction.
• General anesthesia surgery within 48 hours;
• ECG QT interval: male >450 mm seconds, female >470 ms.
• Failure to obtain informed consent or authorization;
• Participate in other exploratory clinical trials within 6 months prior to screening;
• Severe hemodynamic instability (requires epinephrine greater than 0.5ug/kg/min to maintain MAP>65mmHg, or malignant arrhythmias frequently occur)
• Use of monoamine oxidase inhibitors.
• Chronic pain requires long-term analgesics (>3 months).
• Severe, pre-existing substantial liver disease with clinically significant portal hypertension, Child-Pugh grade C cirrhosis, or acute liver failure;
• Patients with acute and chronic renal insufficiency requiring dialysis treatment;
• Severe craniocerebral injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, epileptic status, etc.
• Patients with a history of alcohol or drug abuse;
• Any condition that prevents the correct assessment of cognitive function, such as speech and sensory disorders or mental disorders (language difficulties or organic mental dysfunction);
• any other conditions which the investigator considers inappropriate for registration.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RASS score	The RASS score at 5, 10, 30 minutes and 1, 2, 3, 4, 8, 12, 16, 20, 24 hours post- dose and before and after each dose adjustment.	Richmond Agitation and Sedation Scale score was used to assess the patient's calm state.The maximum value of the score table is 5 and the minimum value is - 4， indicating that the patient 's sedation level changes from ' coma ' to ' aggressive '.The higher the score, the worse the patient 's sedation depth and sedation quality.
CPOT score	The CPOT score at 5, 10, 30 minutes and 1, 2, 3, 4, 8, 12, 16, 20, 24 hours post- dose and before and after each dose adjustment.	Critical care Pain Observation Tool score is used to evaluate the degree of pain in critically ill patients.The maximum value of the score table is 10, and the minimum value is 0.The higher the score, the more serious the pain of the patient.

Trial Locations

Locations (1)

Emergency Department of Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China