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Impact of Various Sedation Regimens on the Incidence of Delirium

Primary Purpose

Delirium

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine,midazolam
Propofol,midazolam
Sponsored by
Shandong Provincial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring Sedation;, ARDS;, Mechanical ventilation, Hypnotics, Antianxiety Drugs, Causing, Adverse Effects, Therapeutic Use

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HeNan Tumor Hospital
  • The Second Hospital of Shandong University
  • Affiliated Hospital of Jining Medical University
  • Liaocheng Hospital
  • Linyi People's Hospital
  • Affiliated Hospital of Weifang Medical University
  • Central Hospital of Zibo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexmedetomidine,midazolam

Propofol,midazolam

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence rates and duration of delirium
Incidence rates and duration of delirium within 14 days after initiation of sedation with dexmedetomidine or propofol
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.

Secondary Outcome Measures

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

Full Information

First Posted
April 16, 2014
Last Updated
July 15, 2014
Sponsor
Shandong Provincial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02117726
Brief Title
Impact of Various Sedation Regimens on the Incidence of Delirium
Official Title
Impact of Various Sedation Regimens on the Incidence of Post-sedation Delirium in Patients Receiving Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Provincial Hospital

4. Oversight

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Sedation;, ARDS;, Mechanical ventilation, Hypnotics, Antianxiety Drugs, Causing, Adverse Effects, Therapeutic Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine,midazolam
Arm Type
Experimental
Arm Description
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.
Arm Title
Propofol,midazolam
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine,midazolam
Intervention Type
Drug
Intervention Name(s)
Propofol,midazolam
Primary Outcome Measure Information:
Title
Incidence rates and duration of delirium
Description
Incidence rates and duration of delirium within 14 days after initiation of sedation with dexmedetomidine or propofol
Time Frame
up to 15 days
Title
Sedation interruption
Description
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.
Time Frame
up to 5 days
Secondary Outcome Measure Information:
Title
Sedation therapy effect
Description
The frequency of assessment whose score fall within the target range.
Time Frame
up to 7 days
Title
Hospitalized days in ICU
Time Frame
up to 15 days
Title
Death rates
Description
Patients' death rates with a follow-up of 28 days
Time Frame
28 days
Title
Incidence rate of patients self-extubation
Time Frame
up to 7 days
Title
Injection speed, total dose and injection of sedatives in different groups.
Time Frame
7 days
Title
Additional dose of fentanyl and midazolam
Time Frame
up to 7 days
Title
Dosage of diuretic, antiemetic, hypoglycemic, beta-receptor antagonist and vasoactive agents.
Time Frame
up to 15 days
Title
Variation degree of HR, RR, BP and SpO2
Time Frame
up to 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
HeNan Tumor Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Xing, physician
Phone
400-0371-818
Email
xfsally2007@163.com
First Name & Middle Initial & Last Name & Degree
Fang Xing, Physician
Facility Name
The Second Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250033
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengen Ma
Phone
+86 15153169727
Email
chengen99@163.com
Facility Name
Affiliated Hospital of Jining Medical University
City
Jining
State/Province
Shandong
ZIP/Postal Code
272000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiwei Yang, Physician
Phone
+86 13518675416
Email
yhw200465@126.com
Facility Name
Liaocheng Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiejun Wu, physician
Phone
+86 13306352913
Email
wtj0721@163.com
Facility Name
Linyi People's Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tingfa Zhou
Phone
+86 13013538061
Email
zhoutingfa66@126.com
Facility Name
Affiliated Hospital of Weifang Medical University
City
Weifang
State/Province
Shandong
ZIP/Postal Code
261031
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peirong Zhang, Physician
Phone
15269600599
Email
zhangpeirong@csco.org.cn
Facility Name
Central Hospital of Zibo
City
Zibo
State/Province
Shandong
ZIP/Postal Code
255000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shifu Wang, Physician
Phone
18678186866
Email
wsficu@163.com

12. IPD Sharing Statement

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Impact of Various Sedation Regimens on the Incidence of Delirium

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