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NCT05024799 Clinical Trial

Effect of Different Sedation and Analgesia Strategies on Patients With Mechanical Ventilation

Respiratory Insufficiency Clinical Trial

Official title:
Effect of Different Sedation and Analgesia Strategies on Patients With Mechanical Ventilation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05024799
Other study ID # QYFYKYLL931311920
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date January 2022
Est. completion date December 2024

Study information
Verified date August 2021
Source The Affiliated Hospital of Qingdao University
Contact Jinyan Xing, Dr
Phone 86-0532-82919386
Email xingjy@qdu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Most patients in ICU are treated with a combination of analgesics and sedatives in most cases. Due to the different mechanism of different sedative and analgesic drugs, different antagonistic or synergistic effects may occur when combined with drugs, resulting in different clinical effects, especially significant effects on ventilators for patients with assisted breathing. Therefore, this study hopes to compare the effects of different sedative and analgesic drug combinations on the duration of mechanical ventilation for patients with ventilators, so as to guide the clinical adoption of a more reasonable sedative and analgesic scheme.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults who are treated with sedation and analgesia for invasive mechanical ventilation Exclusion Criteria: - they have baseline severe cognitive impairment; were pregnant or breast-feeding; were blind, deaf ; had second-degree or third-degree heart block or bradycardia requiring intervention; had an allergy to the experimental drugs; had an indication for benzodiazepines; were anticipated to have immediate discontinuation of mechanical ventilation; were expected to have neuromuscular blockade for more than 48 hours; were in a moribund state; or had received mechanical ventilation for more than 96 hours before meeting all inclusion criteria.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fentanyl, propofol
The patients in this group will be administered with fentanyl and propofol
• fentanyl and dexmedetomindine
The patients in this group will be administered with fentanyl and dexmedetomindine
• Butorphanol and propofol
The patients in this group will be administered with butorphanol and propofol
• Butorphanol and dexmedetomindine
The patients in this group will be administered with butorphanol and dexmedetomindine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The Affiliated Hospital of Qingdao University

Outcome
Type Measure Description Time frame Safety issue
Primary ventilator-free days at 28 days at 28 days
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