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Clinical Trials/NCT05024799
NCT05024799
Not yet recruiting
Phase 4

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

The Affiliated Hospital of Qingdao University0 sites300 target enrollmentJanuary 2022

Overview

Phase
Phase 4
Intervention
Fentanyl, propofol
Conditions
Respiratory Insufficiency
Sponsor
The Affiliated Hospital of Qingdao University
Enrollment
300
Primary Endpoint
ventilator-free days at 28 days
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 2022
End Date
December 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

JinyanXing

Director

The Affiliated Hospital of Qingdao University

Eligibility Criteria

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.

Arms & Interventions

F-P group

the combination of fentanyl and propofol

Intervention: Fentanyl, propofol

F-D group

the combination of fentanyl and dexmedetomidine

Intervention: fentanyl and dexmedetomindine

B-P group

the combination of butorphanol and propofol

Intervention: Butorphanol and propofol

B-D group

the combination of butorphanol and dexmedetomidine

Intervention: Butorphanol and dexmedetomindine

Outcomes

Primary Outcomes

ventilator-free days at 28 days

Time Frame: at 28 days

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