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

Phase 2

Recruiting

• Conditions: Respiratory Insufficiency
• Interventions: Drug: Nalbuphine hydrochloride injection; Drug: Hydromorphone hydrochloride injection

• Registration Number: NCT06785571
• Lead Sponsor: Wuhan Union Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-30
• Status Verified: 2024-10
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-19
• Last Update Submitted: 2025-01-19
• Study First Posted: 2025-01-21
• Last Update Posted: 2025-01-21
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lower loading dose of Nalbuphine hydrochloride for step 1	Nalbuphine hydrochloride injection	Nalbuphine hydrochloride injection, a loading dose of 4 mg administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0\~5.0mg/h)
higher loading dose of Nalbuphine hydrochloride for step 1	Nalbuphine hydrochloride injection	Nalbuphine hydrochloride injection, a loading dose of 6 mg administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0\~5.0mg/h)
Hydromorphone hydrochloride injection for step 1	Hydromorphone hydrochloride injection	Hydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h)
The optimal loading of Nalbuphine hydrochloride injection for step 2	Nalbuphine hydrochloride injection	Nalbuphine hydrochloride injection: a loading dose determined after step 1 administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0\~5.0mg/h)
Hydromorphone hydrochloride injection for step 2	Hydromorphone hydrochloride injection	Hydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h)

Primary Outcome Measures

Name	Time	Method
The analgesic success rate	Within 24 hours while receiving the study drug	The analgesic success is determined as 1) no use of rescue analgesic medication and 2) at least 70% of the time with CPOT ≤ 2 points

Secondary Outcome Measures

Name	Time	Method
The percentage of time with light sedation duration	Within 24 hours while receiving the study drug	Light sedation duration is defined as subjects with CPOT ≤ 2 points and -2 points ≤ RASS ≤ 1
The amout of propfol used	Within 24 hours while receiving the study drug	The amout of propfol used
Successful extubation	Within 24 hours while receiving the study drug	Successful extubated without reintubation

Trial Locations

Locations (1)

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China