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

Phase 4

Not yet recruiting

• Conditions: Respiratory Insufficiency
• Interventions: Drug: Butorphanol and dexmedetomindine; Drug: Butorphanol and propofol; Drug: Fentanyl, propofol; Drug: fentanyl and dexmedetomindine

• Registration Number: NCT05024799
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-26
• Last Update Submitted: 2021-08-26
• Study First Posted: 2021-08-27
• Last Update Posted: 2021-08-27
• Study Start: 2022-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B-D group	Butorphanol and dexmedetomindine	the combination of butorphanol and dexmedetomidine
B-P group	Butorphanol and propofol	the combination of butorphanol and propofol
F-P group	Fentanyl, propofol	the combination of fentanyl and propofol
F-D group	fentanyl and dexmedetomindine	the combination of fentanyl and dexmedetomidine

Primary Outcome Measures

Name	Time	Method
ventilator-free days at 28 days	at 28 days