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Comparitive efficacy of hydromorphone and sufentanil in mechanically ventilated ICU patients: an open, randomized controlled, non-inferiority study

Comparitive efficacy of hydromorphone and sufentanil in mechanically ventilated ICU patients: an open, randomized controlled, non-inferiority study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103498
Enrollment
Unknown
Registered
2025-05-30
Start date
2025-06-02
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

mechanical ventilated patients

Interventions

Hydromorphinone group:Relieve pain with intravenous hydromorphinone
Sufentanil group:Relieve pain with intravenous sufentanil

Sponsors

Shandong Provincial Hospital Affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. ICU patients who are intubated and are expected to require invasive mechanical ventilation for more than 48 hours; 2. Patients who are judged by clinicians to require analgesic treatment; 3. Be between 18 and 80 years old.

Exclusion criteria

Exclusion criteria: 1. Other acute or chronic pain: such as history of surgery within 7 days, chronic cancer pain, chronic pain after herpes virus infection, etc.; 2. Use (oral or intravenous) opioid painkillers for more than 24 hours before enrollment; 3. Presence of severe multi-organ failure, APACHE II score >=35 points; 4. Patients who require deep sedation (RASS -4/-5) or need muscle blocking agents due to their condition, such as severe ARDS, rib fractures, abnormal breathing, traumatic brain injury, status epilepticus, etc.; 5. Patients who are unable to complete CPOT or RASS scores: such as coma, paralysis, cervical spinal cord lesions, motor neuron disease, etc.; 6. Patients with contraindications to the use of hydromorphone, sufentanil, propofol, dexmedetomidine, such as liver failure (Child-Pugh class C), severe renal failure (creatinine clearance =0.2ug/kg/min norepinephrine or corresponding equivalent dose of vasopressor to maintain MAP>=50mmHg); 8. Pregnancy or lactation;

Design outcomes

Primary

MeasureTime frame
The proportion of patients with satisfactory analgesia during the study period;

Secondary

MeasureTime frame
The time to satisfactory CPOT analgesia score;The time to satisfactory RASS analgesia score;The proportion of CPOT satisfactory score within 6 hour;The proportion of RASS satisfactory score within 6 hour;The time to tracheal intubation removal after discontinuation of analgesic and sedative drugs;The dosage of study drug (µg/kg/h); The duration of study drug administration;The proportion of CPOT satisfactory score within 12 hour;The proportion of CPOT satisfactory score within 24 hour;The proportion of satisfactory RASS score within 12 hour;The proportion of satisfactory RASS score within 24 hour;

Countries

China

Contacts

Public ContactJinjiao Jiang

Shandong Provincial Hospital Affiliated to Shandong First Medical University

jjjsch@163.com+86 186 7887 7551

Outcome results

None listed

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