Impact of Various Sedation Regimens on the Incidence of Delirium

Delirium Clinical Trial

Official title:

Impact of Various Sedation Regimens on the Incidence of Post-sedation Delirium in Patients Receiving Mechanical Ventilation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02117726
• Other study ID #: ARDS2014
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 16, 2014
• Last updated: July 15, 2014
• Start date: May 2014

Study information

• Verified date: July 2014
• Source: Shandong Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• Dexmedetomidine,midazolam

• Propofol,midazolam

Locations

Country	Name	City	State
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	HeNan Tumor Hospital	Zhengzhou	Henan
China	Central Hospital of Zibo	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rates and duration of delirium	Incidence rates and duration of delirium within 14 days after initiation of sedation with dexmedetomidine or propofol	up to 15 days	No
Primary	Sedation interruption	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.	up to 5 days	No
Secondary	Sedation therapy effect	The frequency of assessment whose score fall within the target range.	up to 7 days	No
Secondary	Hospitalized days in ICU		up to 15 days	No
Secondary	Death rates	Patients' death rates with a follow-up of 28 days	28 days	No
Secondary	Incidence rate of patients self-extubation		up to 7 days	No
Secondary	Injection speed, total dose and injection of sedatives in different groups.		7 days	No
Secondary	Additional dose of fentanyl and midazolam		up to 7 days	No
Secondary	Dosage of diuretic, antiemetic, hypoglycemic, beta-receptor antagonist and vasoactive agents.		up to 15 days	No
Secondary	Variation degree of HR, RR, BP and SpO2		up to 15 days	No