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

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Drug: Fentanyl, propofol
* Drug: fentanyl and dexmedetomindine
* Drug: Butorphanol and propofol
* Drug: Butorphanol and dexmedetomindine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F-P group<br>the combination of fentanyl and propofol | Drug: Fentanyl, propofol<br>* The patients in this group will be administered with fentanyl and propofol<br>|
| Experimental: F-D group<br>the combination of fentanyl and dexmedetomidine | Drug: fentanyl and dexmedetomindine<br>* The patients in this group will be administered with fentanyl and dexmedetomindine<br>|
| Experimental: B-P group<br>the combination of butorphanol and propofol | Drug: Butorphanol and propofol<br>* The patients in this group will be administered with butorphanol and propofol<br>|
| Experimental: B-D group<br>the combination of butorphanol and dexmedetomidine | Drug: Butorphanol and dexmedetomindine<br>* The patients in this group will be administered with butorphanol and dexmedetomindine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilator-free days at 28 days |  | at 28 days |