Study on the application value of Oxycodone Hydrochloride Injection for analgesia in ICU patients with invasive mechanical ventilation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500095714

Enrollment

Unknown

Registered

2025-01-10

Start date

2025-01-30

Completion date

Unknown

Last updated

2025-01-13

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

Conditions

None

Interventions

Remifentanil hydrochloride group:Tracheal intubation was performed at the time of enrollment: (remifentanil hydrochloride for injection group) anesthesia induction: remifentanil hydrochloride 0.5-1.0u

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age >=18 years old; (2) Admitted to ICU and received invasive mechanical ventilation treatment; (3) Expected invasive mechanical ventilation time >24 hours; (4) Obtain informed consent from the patient’s family.

Exclusion criteria

Exclusion criteria: (1) Age > 80 years old; (2) Patients with severe burns; (3) Patients with neurological impairment, mental illness, dementia or who are unable to communicate with medical staff due to language barriers; (4) Patients with severe central nervous system diseases; (5) Patients with severe cardiac insufficiency receiving ECMO treatment; (6) Patients whose condition requires continuous deep sedation or who are unable to perform daily awakenings; (7) Pregnant or lactating women; (9) Patients who are allergic to or have contraindications to the pharmaceutical ingredients in this study; (10) GCS score less than 13 points; (11) Chronic kidney disease (creatinine clearance <10 ml/min), severe liver dysfunction (Child-Pugh grade C or above).

Design outcomes

Primary

Measure	Time frame
Effectiveness indicators of the analgesic effect of the study drug: the percentage of time to reach the target analgesia depth (target analgesia CPOT score <3 points) during the administration of the study drug, the dose of oxycodone to reach the target analgesia, and recovery after drug withdrawal. time (oxycodone hydrochloride and remifentanil hydrochloride are compared according to the potency ratio with morphine converted into morphine doses);;Incidence of adverse reactions during medication;	—

Measure

Time frame

Effectiveness indicators of the analgesic effect of the study drug: the percentage of time to reach the target analgesia depth (target analgesia CPOT score <3 points) during the administration of the study drug, the dose of oxycodone to reach the target analgesia, and recovery after drug withdrawal. time (oxycodone hydrochloride and remifentanil hydrochloride are compared according to the potency ratio with morphine converted into morphine doses);;Incidence of adverse reactions during medication;

—

Secondary

Measure	Time frame
ICU case fatality rate; Main organ function indicators;Time to invasive mechanical ventilation;Length of ICU stay;Length of hospital stay;	—

Countries

China

Contacts

Public ContactQiang Li

Fushun County People's Hospital

xiaoqiang0403@163.com+86 188 2887 7788

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026