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Clinical Trials in China / NCT06848452
Starting soon Observational

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

NCT06848452 · tracked via the Priya Life Science China tracker
Sponsor
Affiliated Hospital of Nantong University
Phase
Observational
Started
2025-03
Last updated
2025-03-14

Condition(s) studied

AnalgesiaICU Patients Requiring Invasive Mechanical Ventilation

Investigational drug(s) / intervention(s)

no-intervention

no-intervention: no-intervention

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Emergency Department of Affiliated Hospital of Nantong University Nantong Jiangsu

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06848452 on ClinicalTrials.gov ↗ ← All trials in China