Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06037330
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-08-17
Brief Title:
Nalbuphine in ARDS Patients After Surgery
Sponsor:
Hairong Chen
Organization:
Qianfoshan Hospital
Study Overview
Official Title:
Analgesic Effect and Safety Analysis of Nalbuphine in ARDS Patients After Surgery
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None