RecruitingNot ApplicableNCT06203405

The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial


Sponsor

Siriraj Hospital

Enrollment

214 participants

Start Date

Dec 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial aims to assess the efficacy of sedation protocol targeting optimal respiratory drive using P0.1 and arousal level compared with conventional sedation strategy (targeting arousal level alone) in patients requiring mechanical ventilation in the medical intensive care unit.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cisatracurium, a drug called Dexmedetomidine, and others for people with critical illness, lung injury, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETitrating sedation targeting both optimal P0.1 and appropriate arousal level

* Sedation will be adjusted initially to target light sedation (RASS 0 to -2). * Sedative drugs include IV fentanyl (25-75 mcg/h), midazolam (0.02- 0.1 mg/kg/h), propofol (5-50 mcg/kg/min), dexmedetomidine (0.2-0.7 mcg/kg/h). * Deep sedation and neuromuscular blocking agents are allowed to facilitate mechanical ventilation adjustment in patients with refractory hypoxemia. * Dose of cisatracurium is 0.15-0.2 mg/kg intravenous bolus, then continuous infusion at 5 -20 mg/h. * Then sedation adjustment will be guided by P0.1 measurement. * If P0.1 value of 1.5-3.5 cmH2O is achieved, no further adjustment is required. * If P0.1 value \<1.5, sedation will be reduced. * If P0.1 value \>3.5, sedation will be increased. * If P0.1 value is still \>3.5 with deep sedation, cisatracurium will be allowed and titrated until P0.1 value \<3.5 cmH2O. * The study protocol will be continued for 48 hours or until the patients are considered ready for weaning.

DRUGFentanyl

Continuous intravenous infusion of fentanyl 25-75 micrograms/hour

DRUGMidazolam

Continuous intravenous infusion of midazolam 0.02 - 0.1 milligrams/kilogram/hour

DRUGPropofol

Continuous intravenous infusion of propofol 5 - 50 micrograms/kilogram/minute

DRUGDexmedetomidine

Continuous intravenous infusion of dexmedetomidine 0.2 - 0.7 micrograms/kilogram/hour

DRUGCisatracurium

Continuous intravenous infusion of cisatracurium 5 - 20 milligrams/hour


Locations(1)

Siriraj Hospital

Bangkok, Bangkok, Thailand

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NCT06203405


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