NCT06785571 The Evaluation of the Effectiveness and Safety of Nalbuphine Hydrochloride Injection for Analgesia in ICU Patients: A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial
| NCT ID | NCT06785571 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Respiratory Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2023-08-30 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 204 participants in total. It began in 2023-08-30 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The analgesic effect of nalbuphine hydrochloride injection will be evaluated in a multicenter, randomized, single-blind, parallel, positive-controlled approach in two steps: step 1, to explore the optimal dosage of nalbuphine hydrochloride injection with 2 experimental arms and 1 positive control and step 2, to evaluate the effectiveness and safety of nalbuphine hydrochloride injection in mechanically ventilated ICU patients at a dosage determined in step 1 with the same positive control.
Eligibility Criteria
Inclusion Criteria: 1. ICU patients who are intubated are expected to require mechanical ventilation for more than 6h 2. patients or their guardians have a full understanding of the purpose and significance of this trial, and voluntarily participate in this clinical trial and sign an informed consent form Exclusion Criteria: 1. Allergy or unsuitability to any composition of study drugs or propofol 2. Living expectancy of less than 48 hours 3. Neurological disorder and any other condition interfering with sedation assessment 4. Gastrointestinal obstruction 5. Asthmatic 6. Abdominal compartment syndrome 7. Serious hepatic dysfunction (CTP 10-15) 8. Acute kidney injury (KDIGO stage 2 or 3) or Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/min/1.73m2 9. Circulatory instability (the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain proper blood pressure) 10. Need deep sedation or paralytics 11. Anticipation to receive operations (including tracheotomy) 12. Abuse of controlled substances or alcohol 13. Pregnancy, lactation, or an intention of gestation in 6 months 14. Inclusion in another interventional trial in the past 30 days 15. Other conditions deemed unsuitable to be included
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06785571 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Respiratory Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06785571 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06785571 currently recruiting?
Yes, NCT06785571 is actively recruiting participants. Contact the research team at you_shanghust@163.com for enrollment information.
Where is the NCT06785571 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06785571 clinical trial?
NCT06785571 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 204 participants.