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)
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 sites (1)
Facility
City
Region
Status
Emergency Department of Affiliated Hospital of Nantong University
Nantong
Jiangsu
More Affiliated Hospital of Nantong University trials in China
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.
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