Clinical trial NCT06848452: Clinical Study on the Efficacy and Safety of Hydromorphone for ICU Analgesia
Official title: Clinical Study on the Efficacy and Safety of Hydromorphone for ICU Analgesia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Analgesia
ICU Patients Requiring Invasive Mechanical Ventilation
Keywords: ICU
hydromorphone
analgesia
remifentanil
sedation
respirator support
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients undergoing invasive mechanical ventilation requiring analgesia and sedation

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.

Eligibility criteria: 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 outcomes:
measure: RASS score
timeFrame: 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.
measure: CPOT score
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: Emergency Department of Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
References:
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