Efficacy and safety of hydromorphone versus fentanyl for analgesia in ICU mechanically ventilated patients

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100053560

Enrollment

Unknown

Registered

2021-11-24

Start date

2021-12-01

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Fentany group:Intravenous fentanyl

Hydromorhpone group:Hydromorphone infusion

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged >= 18 years and < 80 years; 2. The research complies with the Declaration of Helsinki and China's clinical trial research regulations, and the patients or their family members are informed and agree to participate in the trial; 3. Patients admitted to the ICU, 100 < PaO2/FiO2 < 300, receiving mechanical ventilation, the expected ventilation time exceeds 24 hours, and the mechanical ventilation time is less than 24 hours at the time of enrollment.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breastfeeding; 2. Patients with acute or severe bronchial asthma; 3. Patients with acute intestinal obstruction; 4. Nervous system diseases (history of new stroke patients, history of severe head trauma, cerebral infarction, mental illness, etc.); 5. Severe hemodynamic instability (NE>0.2µg/kg/min); 6. Intolerance to any drug; 7. Use of monooxygenase inhibitors (MAOIs); 8. Chronic pain requires long-term use of analgesics; 9. Abnormal liver or kidney function (liver function above Child grade C, definition of abnormal renal function: chronic renal insufficiency stage III and above, receiving renal replacement therapy, nephrotic syndrome, AKI (KDIGO stage II) and above, etc.) .

Design outcomes

Primary

Measure	Time frame
The percentage of time spent in the target analgesic range during the administration of the study drug;Incidence of gastrointestinal dysfunction;Incidence of respiratory depression rate after extubation;	—

Secondary

Measure	Time frame
Dosage of analgesics;Remedial analgesic drug administration times;Using time and dosage of Propofol;The time of mechanical ventilation;Length of stay in ICU;28-day mortality;Incidence of delirium;The first extubation failed;The incidence of liver and kidney damage;Medical-related expenses;	—

Countries

China

Contacts

Public ContactHuang Xiaobo

Sichuan Academy of Medical Sciences/Sichuan Provincial People's Hospital

drhuangxb@163.com+86 18981838938

Outcome results