Skip to content

Effect of hydromorphone hydrochloride on the success rate of early weaning in mechanically ventilated patients with endotracheal intubation: a multicenter, randomized controlled clinical study

Effect of hydromorphone hydrochloride on the success rate of early weaning in mechanically ventilated patients with endotracheal intubation: a multicenter, randomized controlled clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065256
Enrollment
Unknown
Registered
2022-11-01
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who were extubated offline in the intensive care unit

Interventions

Remifentanil out of the unit:The rate at which remifentanil infusion should be stopped or reduced at the start of the spontaneous breathing trial was at the discretion of the physician, depending on t
Hydromorphone withdrawal unit:Remifentanil was stopped 5 minutes before the spontaneous breathing test, and hydromorphone 1mg was injected intravenously. After 5 minutes, the CPOT score was performed.

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-75 years; 2. ICU patients who underwent mechanical ventilation with endotracheal intubation for various reasons for more than 24 hours, who underwent mechanical ventilation with endotracheal intubation for various reasons and were prepared to enter the weaning stage after evaluation by clinicians (the causes of acute respiratory failure have been removed; Gas exchange can meet the basic requirements of the body, for example, when PEEP<=5cmH2O and FiO2<=0.40, PaO2 is higher than 60mmHg; Glasgow coma score above 13; The body temperature is below 38 degrees Celsius; Vasoactive drugs are not required); 3. Remifentanil was used for analgesia during maintenance of mechanical ventilation; 4. Patients or their family members voluntarily signed informed consent and participated in the study.

Exclusion criteria

Exclusion criteria: 1. The duration of mechanical ventilation was more than 3 weeks; 2. Pregnant and lactating women; 3. Long-term use of psychotropic drugs, long-term use of opioids or history of opioid addiction, drug and alcohol abuse; 4. there is allergy to any study drug; 5. Mental diseases and cognitive disorders; 6. Have participated in this study or any other clinical drug study at the same time; 7. any conditions that may seriously interfere with the collection of research data; 8.Patients deemed ineligible for the study by the investigator.

Design outcomes

Primary

MeasureTime frame
The success rate of the first weaning;

Secondary

MeasureTime frame
Heart rate, blood pressure, respiratory rate, SPO2 and CPOT score during spontaneous breathing test;Extubation and reintubation rate after the first spontaneous breathing test;Heart rate, blood pressure, respiratory rate, SPO2, and visual analogue pain scale (VAS) at 30 minutes after extubation.;

Countries

China

Contacts

Public ContactKejian Qian

The First Affiliated Hospital of Nanchang University

2682244275@qq.com+86 13870998074

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026