Impact of Various Sedation Regimens on the Incidence of Delirium

Phase 4

• Conditions: Delirium
• Interventions: Drug: Dexmedetomidine,midazolam; Drug: Propofol,midazolam

• Registration Number: NCT02117726
• Lead Sponsor: Shandong Provincial Hospital

Brief Summary

Sedation drugs that are commonly used in ICU in treatment of ARDS, includes propofol, midazolam and dexmedetomidine . Among these, both dexmedetomidine and propofol have been reported to be used together with midazolam in ICU and the combination of propofol and midazolam is most commonly used, but things follow include a high incidence rate of delirium, But the combination of midazolam and dexmedetomidine may have complementary advantages and could have be a better choice for sedation. In this study, we attempted to observe the effects of two different drug regimens on delirium incidence rates in severe ARDS patients' : midazolam and propofol vs propofol and dexmedetomidine .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-21
• Study Start: 2014-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-15
• Last Update Posted: 2014-07-16
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Subjects willing to give written informed consent.
• Mild, moderate or severe ARDS patients demanding invasive mechanical ventilation.
• Subjects whose expected time of mechanical ventilation is longer than 24 hours.
• Subjects aged between 18 and 70.

Exclusion Criteria

• Subjects with extremely unstable circulation, whose SBP lower than 90mmHg after volume expansion or pressor agent treatment.
• Subjects with extremely unstable circulation, whose SBP lower than 90mmHg after volume expansion or pressor agent treatment.
• Subjects with heart rates less than 50 beats per minute.
• Subjects with second or third degree atrioventricular block.
• Subjects with serious cerebral injury, severe neurologic disorder (e.g acute stroke, uncontrolled epilepsy and severe dementia) or coma.
• Subjects with acute or severe liver disease (Child-Pugh class C), see attachment 2.
• ARDS patients caused by pulmonary fibrosis or COPD.
• Subjects on all types hemodialysis.
• Subjects with neuromuscular system disease, alcohol withdrawal syndrome or mental disease before entrance of ICU.
• Subjects suspected of narcotic analgesics abusing.
• Subjects needing neuromuscular blocking agents (except intubation).
• Subjects allergic to investigational products or with other contraindication.
• Subjects who are breastfeeding or pregnant
• Subjects participated in other study within 30 days before entrance of ICU

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine,midazolam	Dexmedetomidine,midazolam	Slow injection of 2mg midazolam every minute and watching patients' reaction until attaining the target level of sedation;midazolam was maintained at 0.02\~0.1mg/kg/h, for 24 hours.Dexmedetomidine will be added at 0.2\~1.4μg/kg/h to maintain sedation.If target sedation level (RASS score) cannot be reached in maximum dose of dexmedetomidine, continuous intravenous infusion of midazolam could be used at 0.02\~0.1mg/kg/h, until the target level is reached.
Propofol,midazolam	Propofol,midazolam	Slow injection of 2mg midazolam every minute and watching patients' reaction until attaining the target level of sedation;midazolam was maintained at 0.02\~0.1mg/kg/h, for 24 hours.Propofol will be added at 0.3\~4mg/kg/h to maintain sedation.If target sedation level (RASS score) cannot be reached in maximum dose of propofol, continuous intravenous infusion of midazolam could be used at 0.02\~0.1mg/kg/h, until the target level is reached.

Primary Outcome Measures

Name	Time	Method
Incidence rates and duration of delirium	up to 15 days	Incidence rates and duration of delirium within 14 days after initiation of sedation with dexmedetomidine or propofol
Sedation interruption	up to 5 days	Eye opening according to the voice orders, eye tracking, clenching fist and nodding are involved in assessment, patients could do 3 of those or more is deemed as conscious and taken in delirium assessment.

Secondary Outcome Measures

Name	Time	Method
Hospitalized days in ICU	up to 15 days
Variation degree of HR, RR, BP and SpO2	up to 15 days
Sedation therapy effect	up to 7 days	The frequency of assessment whose score fall within the target range.
Death rates	28 days	Patients' death rates with a follow-up of 28 days
Incidence rate of patients self-extubation	up to 7 days
Injection speed, total dose and injection of sedatives in different groups.	7 days
Additional dose of fentanyl and midazolam	up to 7 days
Dosage of diuretic, antiemetic, hypoglycemic, beta-receptor antagonist and vasoactive agents.	up to 15 days

Trial Locations

Locations (7)

HeNan Tumor Hospital; 🇨🇳 Zhengzhou, Henan, China

The Second Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

Affiliated Hospital of Jining Medical University; 🇨🇳 Jining, Shandong, China

Liaocheng Hospital; 🇨🇳 Liaocheng, Shandong, China

Linyi People's Hospital; 🇨🇳 Linyi, Shandong, China

Affiliated Hospital of Weifang Medical University; 🇨🇳 Weifang, Shandong, China

Central Hospital of Zibo; 🇨🇳 Zibo, Shandong, China