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

ConditionsAnalgesia ICU Patients Requiring Invasive Mechanical Ventilation

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-75

SponsorAffiliated Hospital of Nantong University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

ICU patients undergoing invasive mechanical ventilation requiring analgesia and sedation

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

no-intervention
Other intervention
no-intervention

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: Patients treated with hydromorphone and midazolam1 intervention

Group B: Patients treated with remifentanil and midazolam1 intervention

Trial outcomes

Primary outcomes

RASS score

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.

Time frame

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.

CPOT score

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.

Time frame

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Affiliated Hospital of Nantong University

Lead sponsor

Source ClinicalTrials.gov

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