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

January 19, 2025 updated by: Wuhan Union Hospital, China
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Union Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lower loading dose of Nalbuphine hydrochloride for step 1
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)
Drug: Nalbuphine hydrochloride injection
a loading dose of Nalbuphine hydrochloride injection 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)
Experimental: higher loading dose of Nalbuphine hydrochloride for step 1
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)
Drug: Nalbuphine hydrochloride injection
a loading dose of Nalbuphine hydrochloride injection 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)
Active Comparator: Hydromorphone hydrochloride injection for step 1
Hydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5~3.0mg/h)
Drug: Hydromorphone hydrochloride injection
A maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5~3.0mg/h)
Experimental: The optimal loading of Nalbuphine hydrochloride injection for step 2
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)
Drug: Nalbuphine hydrochloride injection
a loading dose of Nalbuphine hydrochloride injection 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)
Active Comparator: Hydromorphone hydrochloride injection for step 2
Hydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5~3.0mg/h)
Drug: Hydromorphone hydrochloride injection
A maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5~3.0mg/h)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The analgesic success rate
Time Frame: 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
Within 24 hours while receiving the study drug

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Within 24 hours while receiving the study drug
peak plasma concentration
Within 24 hours while receiving the study drug
The area under the plasma drug concentration-time curve
Time Frame: Within 24 hours while receiving the study drug
The area under the plasma drug concentration-time curve (AUC)
Within 24 hours while receiving the study drug
t1/2
Time Frame: Within 24 hours while receiving the study drug
half-life
Within 24 hours while receiving the study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Collaborators

Yichang Humanwell Pharmaceutical Co., Ltd., China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2023

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 19, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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