Acute Respiratory Distress SyndromePhase 4NCT06037330
Nalbuphine in ARDS Patients After Surgery
A Phase 4 study testing Nalbuphine and Sufentanil in people with Acute Respiratory Distress Syndrome, run by Hairong Chen at 1 site in China.
Trial summary
Critically ill patients need reasonable and moderate analgesic and sedative treatment to eliminate or reduce pain, anxiety and restlessness, improve patient comfort and cooperation, reduce patients' stress response, protect organ function and optimize prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Nalbuphine and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Had undergone surgical treatment within 7 days before enrollment;
- Meet the diagnostic criteria for ARDS proposed at the 2011 Berlin ARDS Definition Conference;
- Age ≥18 years old, gender unlimited;
- Patients admitted to ICU with CPOT score ≥3;
- Stay in ICU ≥48h;
- Sign the informed consent form.
Who cannot join
- APACHE II score ≥23 points;
- Patients with esophageal reflux disease and severe gastrointestinal injury have AGI score ≥3;
- Long-term use of narcotic analgesics, hypnotics and psychotropic drugs;
- Alcohol withdrawal symptoms;
- Severe liver dysfunction (Child-Pugh grade C);
- Patients with bronchial asthma and myasthenia gravis;
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- Patients with severe craniocerebral injury, brain tumor, and increased intracranial pressure are prone to respiratory depression;
- Patients undergoing cardiac surgery under cardiopulmonary bypass;
- Patients who have been enrolled in other clinical trials;
- Study patients with drug allergy or other contraindications;
- Pregnant or lactating women;
- The patient himself or his legally authorized representative is unwilling to sign the informed consent;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Intensive Care Medicine
Jinan, Shandong, 250014
Quanzhen Wang, doctor
About this study
Official title: Analgesic Effect and Safety Analysis of Nalbuphine in ARDS Patients After Surgery
Critically ill patients need reasonable and moderate analgesic and sedative treatment to eliminate or reduce pain, anxiety and restlessness, improve patient comfort and cooperation, reduce patients' stress response, protect organ function and optimize prognosis. As a semi-synthetic opioid receptor agonist-antagonist, nalbuphine can bind to μ, κand δ receptors, has partial antagonistic effect on μ receptor, and is fully activated on κreceptor, with very weak δ receptor activity. Results of a study on the efficacy and safety of nalbuphine for analgesia in ICU patients showed that nalbuphine has sustained and stable analgesic effect for patients with mild to moderate analgesic needs in ICU, the onset time is comparable to sufentanil, and excessive sedation caused by sufentanil can be avoided, and the effect on hemodynamics is small. It can be used as a new choice of analgesic drugs in ICU.
A single-center, randomized, single-blind, prospective study was designed to compare nalbuphine and sufentanil in patients with ARDS after surgery. Sixty patients with ARDS after surgery to be admitted to ICU were randomly divided into experimental group (Nalbuphine group) and control group (Sufentanil group). This study aims to determine the analgesic efficacy and safety of nalbuphine hydrochloride in patients with Acute Respiratory distress syndrome (ARDS) after surgery. The successful development of this study will provide more theoretical basis for the individualized analgesic sedation program for surgical patients.
Read the detailed description
Severe patients need reasonable and moderate analgesic sedation to eliminate or reduce pain, anxiety and agitation, improve comfort and cooperation, reduce stress response, protect organ function and improve prognosis. As a semi-synthetic opioid receptor agonist-antagonist, nalbuphine can bind to μ, κand δ receptors, has partial antagonistic effect on μ receptor, and is fully activated on κreceptor, with very weak δ receptor activity. Nalbuphine exerts powerful analgesic and sedative effects at the spinal cord level, with rapid analgesic effect and long duration, almost no cardiovascular adverse reactions, mild respiratory depression and capping effect, low incidence of nausea, vomiting and skin pruritus, and low addiction. Results of a study on the efficacy and safety of nalbuphine for analgesia in ICU patients showed that nalbuphine has sustained and stable analgesic effect for patients with mild to moderate analgesic needs in ICU, the onset time is comparable to sufentanil, and excessive sedation caused by sufentanil can be avoided, and the effect on hemodynamics is small. It can be used as a new choice of analgesic drugs in ICU. Moreover, nalbuphine theoretically has no σ-receptor excitability, is not hallucinogenic, and the chance of inducing delirium is lower. Studies have shown that nalbuphine can reduce postoperative inflammation and oxidative stress and has a lung protective effect.
This study aims to determine the analgesic efficacy and safety of nalbuphine hydrochloride in patients with Acute Respiratory distress syndrome (ARDS) after surgery, and to explore the effects of nalbuphine hydrochloride on respiratory function, gastrointestinal function and cognitive function. To provide more theoretical basis for individualized analgesic and sedation program for surgical patients. Sixty patients were included and randomly divided into 1:1 groups, with 30 patients in each group. All patients were included according to strict inclusion criteria.
The experimental group was given nalbuphine analgesia and the control group was given sufentanil analgesia. The number of patients reaching the target level of analgesia and sedation at each time node, invasive mechanical ventilation time, oxygenation index change, mortality and other indicators were compared between the two groups.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Nalbuphine, Sufentanil
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
Also called Nalbuphine Hydrochloride Injection
Nalbuphine was injected intravenously. The target CPOT score was <2, and the target RASS score was -2 ~ 1. 40 mg of nalbuphine was diluted into 50 mL solution, the load was 0.1mg/kg, the maintenance dose was 0.04-0.08mg/kg/h, the CPOT score was <2, and the maximum daily dose was 160mg.
SufentanilDrug
Also called Sufentanil citrate Injection
Sufentanil was injected intravenously, and the target CPOT score was <2, and the target RASS score was -2 ~ 1. 0.1mg of sufentanil was diluted into 50 mL solution, the loading dose was 0.2-0.5μg/kg, the maintenance dose was 0.2-0.3μg/kg/h, and the CPOT score was <2 points
| Study group | Role | What they receive |
|---|---|---|
| Nalbuphine group | Experimental | 40 mg of nalbuphine was diluted into 50 mL solution, the load dose was 0.1mg/kg, the maintenance dose was 0.04-0.08mg/kg/h, the CPOT score was <2, and the daily maximum dose was 160mg. Receives: Drug: Nalbuphine |
| Sufentanil group | Active comparator | 0.1mg of sufentanil was diluted into 50 mL solution, the loading dose was 0.2-0.5μg/kg, the maintenance dose was 0.2-0.3μg/kg/h, and the CPOT score was <2 points. Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number 1 of patients who achieved the target level of analgesia and sedation
The number of patients in the two groups who reached the target level of analgesia and sedation within 30 minutes after the administration of analgesic drugs was compared
Measured: 30 minutes after the analgesic is administered
Number 2 of patients who achieved the target level of analgesia and sedation
The number of patients in the two groups who reached the target level of analgesia and sedation within 60 minutes after the administration of analgesic drugs was compared
Measured: 60 minutes after the analgesic is administered
Number 3 of patients who achieved the target level of analgesia and sedation
The number of patients in the two groups who reached the target level of analgesia and sedation within 4 hours after the administration of analgesic drugs was compared
Measured: 4 hours after the analgesic is administered
Number 4 of patients who achieved the target level of analgesia and sedation
The number of patients in the two groups who reached the target level of analgesia and sedation within 8 hours after the administration of analgesic drugs was compared
Measured: 8 hours after the analgesic is administered
Number 5 of patients who achieved the target level of analgesia and sedation
The number of patients in the two groups who reached the target level of analgesia and sedation within 12 hours after the administration of analgesic drugs was compared
Measured: 12 hours after the analgesic is administered
Number 6 of patients who achieved the target level of analgesia and sedation
The number of patients in the two groups who reached the target level of analgesia and sedation within 24 hours after the administration of analgesic drugs was compared
Measured: 24 hours after the analgesic is administered
Comparison of invasive mechanical ventilation time
Invasive mechanical ventilation time was compared between the two groups
Measured: The time from the start of the tracheal intubation to the withdrawal of the ventilator, assessed up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Sep 2023
- Primary completion28 Apr 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hairong Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hairong Chen, Qianfoshan Hospital
- Investigators
- Hairong Chen, doctor, Study director, Qianfo Mountain Hospital, Shandong Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037330
- Sponsor's protocol ID
- QFSYXLL-KY-2022(092)
- Status last verified
- Mar 2024
- First submitted
- 17 Aug 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zacny JP, Conley K, Galinkin J. Comparing the subjective, psychomotor and physiological effects of intravenous buprenorphine and morphine in healthy volunteers. J Pharmacol Exp Ther. 1997 Sep;282(3):1187-97.
PubMed 9316825
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect and Safety Analysis of Nalbuphine in ARDS Patients After Surgery
- ClinicalTrials.gov ID
- NCT06037330
- Acronym / sponsor ID
- QFSYXLL-KY-2022(092)
- Conditions
- Acute Respiratory Distress Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hairong ChenUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 28 Apr 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Critically ill patients need reasonable and moderate analgesic and sedative treatment to eliminate or reduce pain, anxiety and restlessness, improve patient comfort and cooperation, reduce patients' stress response, protect organ function and optimize prognosis. As a semi-synthetic opioid receptor agonist-antagonist, nalbuphine can bind to μ, κand δ receptors, has partial antagonistic effect on μ receptor, and is fully activated on κreceptor, with very weak δ receptor activity. Results of a study on the efficacy and safety of nalbuphine for analgesia in ICU patients showed that nalbuphine has sustained and stable analgesic effect for patients with mild to moderate analgesic needs in ICU, the onset time is comparable to sufentanil, and excessive sedation caused by sufentanil can be avoided, and the effect on hemodynamics is small. It can be used as a new choice of analgesic drugs in ICU.
A single-center, randomized, single-blind, prospective study was designed to compare nalbuphine and sufentanil in patients with ARDS after surgery. Sixty patients with ARDS after surgery to be admitted to ICU were randomly divided into experimental group (Nalbuphine group) and control group (Sufentanil group). This study aims to determine the analgesic efficacy and safety of nalbuphine hydrochloride in patients with Acute Respiratory distress syndrome (ARDS) after surgery. The successful development of this study will provide more theoretical basis for the individualized analgesic sedation program for surgical patients.
Detailed description
Severe patients need reasonable and moderate analgesic sedation to eliminate or reduce pain, anxiety and agitation, improve comfort and cooperation, reduce stress response, protect organ function and improve prognosis. As a semi-synthetic opioid receptor agonist-antagonist, nalbuphine can bind to μ, κand δ receptors, has partial antagonistic effect on μ receptor, and is fully activated on κreceptor, with very weak δ receptor activity. Nalbuphine exerts powerful analgesic and sedative effects at the spinal cord level, with rapid analgesic effect and long duration, almost no cardiovascular adverse reactions, mild respiratory depression and capping effect, low incidence of nausea, vomiting and skin pruritus, and low addiction. Results of a study on the efficacy and safety of nalbuphine for analgesia in ICU patients showed that nalbuphine has sustained and stable analgesic effect for patients with mild to moderate analgesic needs in ICU, the onset time is comparable to sufentanil, and excessive sedation caused by sufentanil can be avoided, and the effect on hemodynamics is small. It can be used as a new choice of analgesic drugs in ICU. Moreover, nalbuphine theoretically has no σ-receptor excitability, is not hallucinogenic, and the chance of inducing delirium is lower. Studies have shown that nalbuphine can reduce postoperative inflammation and oxidative stress and has a lung protective effect.
This study aims to determine the analgesic efficacy and safety of nalbuphine hydrochloride in patients with Acute Respiratory distress syndrome (ARDS) after surgery, and to explore the effects of nalbuphine hydrochloride on respiratory function, gastrointestinal function and cognitive function. To provide more theoretical basis for individualized analgesic and sedation program for surgical patients. Sixty patients were included and randomly divided into 1:1 groups, with 30 patients in each group. All patients were included according to strict inclusion criteria.
The experimental group was given nalbuphine analgesia and the control group was given sufentanil analgesia. The number of patients reaching the target level of analgesia and sedation at each time node, invasive mechanical ventilation time, oxygenation index change, mortality and other indicators were compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nalbuphine group | Experimental | Drug: Nalbuphine40 mg of nalbuphine was diluted into 50 mL solution, the load dose was 0.1mg/kg, the maintenance dose was 0.04-0.08mg/kg/h, the CPOT score was <2, and the daily maximum dose was 160mg. |
| Sufentanil group | Active comparator | Drug: Sufentanil0.1mg of sufentanil was diluted into 50 mL solution, the loading dose was 0.2-0.5μg/kg, the maintenance dose was 0.2-0.3μg/kg/h, and the CPOT score was <2 points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Had undergone surgical treatment within 7 days before enrollment;
- Meet the diagnostic criteria for ARDS proposed at the 2011 Berlin ARDS Definition Conference;
- Age ≥18 years old, gender unlimited;
- Patients admitted to ICU with CPOT score ≥3;
- Stay in ICU ≥48h;
Key exclusion criteria (12 listed)
- APACHE II score ≥23 points;
- Patients with esophageal reflux disease and severe gastrointestinal injury have AGI score ≥3;
- Long-term use of narcotic analgesics, hypnotics and psychotropic drugs;
- Alcohol withdrawal symptoms;
- Severe liver dysfunction (Child-Pugh grade C);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NalbuphineAlso: Nalbuphine Hydrochloride InjectionNalbuphine was injected intravenously. The target CPOT score was <2, and the target RASS score was -2 ~ 1. 40 mg of nalbuphine was diluted into 50 mL solution, the load was 0.1mg/kg, the maintenance dose was 0.04-0.08mg/kg/h, the CPOT score was <2, and the maximum daily dose was 160mg. | Drug | Nalbuphine group |
| SufentanilAlso: Sufentanil citrate InjectionSufentanil was injected intravenously, and the target CPOT score was <2, and the target RASS score was -2 ~ 1. 0.1mg of sufentanil was diluted into 50 mL solution, the loading dose was 0.2-0.5μg/kg, the maintenance dose was 0.2-0.3μg/kg/h, and the CPOT score was <2 points | Drug | Sufentanil group |
Primary outcome
Number 1 of patients who achieved the target level of analgesia and sedation
Time frame: 30 minutes after the analgesic is administered
The number of patients in the two groups who reached the target level of analgesia and sedation within 30 minutes after the administration of analgesic drugs was compared
Number 2 of patients who achieved the target level of analgesia and sedation
Time frame: 60 minutes after the analgesic is administered
The number of patients in the two groups who reached the target level of analgesia and sedation within 60 minutes after the administration of analgesic drugs was compared
Number 3 of patients who achieved the target level of analgesia and sedation
Time frame: 4 hours after the analgesic is administered
The number of patients in the two groups who reached the target level of analgesia and sedation within 4 hours after the administration of analgesic drugs was compared
Number 4 of patients who achieved the target level of analgesia and sedation
Time frame: 8 hours after the analgesic is administered
The number of patients in the two groups who reached the target level of analgesia and sedation within 8 hours after the administration of analgesic drugs was compared
Number 5 of patients who achieved the target level of analgesia and sedation
Time frame: 12 hours after the analgesic is administered
The number of patients in the two groups who reached the target level of analgesia and sedation within 12 hours after the administration of analgesic drugs was compared
Number 6 of patients who achieved the target level of analgesia and sedation
Time frame: 24 hours after the analgesic is administered
The number of patients in the two groups who reached the target level of analgesia and sedation within 24 hours after the administration of analgesic drugs was compared
Comparison of invasive mechanical ventilation time
Time frame: The time from the start of the tracheal intubation to the withdrawal of the ventilator, assessed up to 28 days
Invasive mechanical ventilation time was compared between the two groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 9316825Zacny JP, Conley K, Galinkin J. Comparing the subjective, psychomotor and physiological effects of intravenous buprenorphine and morphine in healthy volunteers. J Pharmacol Exp Ther. 1997 Sep;282(3):1187-97.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hairong Chen, doctor study director
Qianfo Mountain Hospital, Shandong Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nalbuphine and Sufentanil in people with Acute Respiratory Distress Syndrome, run by Hairong Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quanzhen Wang, doctor (15562570205, wangquanzhen1986@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number 1 of patients who achieved the target level of analgesia and sedation (time frame: 30 minutes after the analgesic is administered). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06037330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.