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Safety and Efficacy of Combined Sedation With Midazolam and Dexmedetomidine in ICU Patients

Primary Purpose

Delirium

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
midazolam
Dexmedetomidine
Fentanyl
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring Intensive care unit, Mechanical ventilation, Combined sedation

Eligibility Criteria

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

Inclusion Criteria:

  1. ICU patients needing sedation
  2. 18 years or older
  3. mechanically ventilated for less than 96 hours prior to start of study drug.

Exclusion Criteria:

  1. Trauma and burn patients as admitting diagnosis.
  2. Dialysis of all types.
  3. Pregnant or lactation.
  4. Neuromuscular blockade other than for intubation.
  5. Epidural or spinal analgesia.
  6. General anesthesia prior to or planned after the start of study drug infusion
  7. Serious central nervous system pathology(acute stroke, uncontrolled seizures,severe dementia).
  8. Acute hepatitis or severe liver disease (Child-Pugh class C).
  9. Unstable angina or acute myocardial infarction.
  10. Left ventricular ejection fraction less than 30%,heart rate less than 50/min. 11.Second or third degree heart block.

12.Allergy to the study drug. 13.Systolic blood pressure less than 90 mm Hg despite continuous infusions of 2 vasopressors before the start of study drug infusion.

14. Patients with renal insufficiency were randomized and treated; however, patients were discontinued if they required dialysis.

Sites / Locations

  • Department ICU, Shandong university affiliated Qilu Hospital.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

midazolam

Dexmedetomidine

midazolam & dexmedetomidine

Arm Description

Initiative dosage of midazolam is 0.05 mg/kg given intravenously, the maintenance dosage is 0.01-0.05 mg/kg/h, drug dosage is adjusted by target sedation level.

The loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min, the maintenance dosage is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level.

Initiative dosage of midazolam is 0.05 mg/kg given intravenously, The loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min(given or not according to patients' condition),. The maintenance dosage of midazolam is 0.01-0.05 mg/kg/h, the maintenance dosage of dexmedetomidine is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level.

Outcomes

Primary Outcome Measures

The total time within target sedation level
Sedation level with RASS score is recorded every 4 hours during sedation. When target sedation was not obtained, sedation drug dosage changed and when adverse event needed to be treated, the sedation level is also recorded. The adjustment of sedation drug is recorded.

Secondary Outcome Measures

The dosage of sedation/analgesic drug
Record the induced and maintained dosage of sedation/opioid analgesic drug. The total dosage of sedation/opioid analgesic drug. The added dosage of midazolam.
Duration of mechanical ventilation
The duration of mechanical ventilation is recorded.
Economic outcome
The cost of sedation drug used is recorded. The cost of mechanical ventilation is recorded. The cost of ICU residency is recorded.
Satisfactory of patients to ICU stay from admitted until discharged from ICU
Evaluated the satisfactory of patients to ICU. Using scores including 0 to 10. 0 presents extremely dissatisfied and 10 presents extremely satisfied.
Delirium
Delirium is evaluated when daily sedation interruption is done during sedation. Delirium incidence is recorded using CAM-ICU. Treatment of delirium is recorded including drug,dosage and method of administration.
Vital signs
Heart rate(HR),main arterial pressure(MAP),respiratory rate(RR),pulse saturate of oxygen(SPO2) are recorded every 4 hours. When sedation drug dosage changed and adverse events treated,the vital signs is also recorded. Gas blood analysis index is recorded when the daily interruption is done and when the SPO2 is less 90% or 10% decrease than normal.
Duration of ICU stay
Record when participants discharged form ICU.

Full Information

First Posted
February 25, 2014
Last Updated
March 5, 2014
Sponsor
Qilu Hospital of Shandong University
Collaborators
Chinese Medical Association
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1. Study Identification

Unique Protocol Identification Number
NCT02080169
Brief Title
Safety and Efficacy of Combined Sedation With Midazolam and Dexmedetomidine in ICU Patients
Official Title
Safety and Efficacy of Combined Sedation With Midazolam and Dexmedetomidine in ICU Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qilu Hospital of Shandong University
Collaborators
Chinese Medical Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
It is well known that ICU patients need sedation. Now no ideal sedation drug existed and every sedation drug has its advantage and disadvantage,so combined sedation may use the advantage and avoid the disadvantage of the sedation drug according to the patients'condition. Until now, there is rare study about the combined sedation or sequenced sedation of different sedation drug.The purpose of the study is to explore the value of combined sedation with midazolam and dexmedetomidine compared to single drug sedation in ICU, so as to seek an ideal sedation protocol that could reduce the cost of treatment,obtain the appropriate sedation not under sedation or over sedation,reduce the incidence of delirium, reduce the adverse event of sedation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Intensive care unit, Mechanical ventilation, Combined sedation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
midazolam
Arm Type
Experimental
Arm Description
Initiative dosage of midazolam is 0.05 mg/kg given intravenously, the maintenance dosage is 0.01-0.05 mg/kg/h, drug dosage is adjusted by target sedation level.
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
The loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min, the maintenance dosage is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level.
Arm Title
midazolam & dexmedetomidine
Arm Type
Experimental
Arm Description
Initiative dosage of midazolam is 0.05 mg/kg given intravenously, The loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min(given or not according to patients' condition),. The maintenance dosage of midazolam is 0.01-0.05 mg/kg/h, the maintenance dosage of dexmedetomidine is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level.
Intervention Type
Drug
Intervention Name(s)
midazolam
Other Intervention Name(s)
Liyuxi
Intervention Description
If the target sedation level is not obtained using the above recommended dosage, midazolam 0.01-0.05 mg/kg is added every 10-15min, until the target sedation level is obtained. If it is over sedation (RASS -3 to -5), and reduction of the dosage of the sedation drug could not ease the situation, and then stop the sedation until the target sedation level is obtained.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Yisi
Intervention Description
If the target sedation level is not obtained using the above recommended dosage, midazolam 0.01-0.05 mg/kg is added every 10-15min, until the target sedation level is obtained. If it is over sedation (RASS -3 to -5), and reduction of the dosage of the sedation drug could not ease the situation, and then stop the sedation until the target sedation level is obtained.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Fentanyl is used as analgesic drug in order to obtain the VAS <3.
Primary Outcome Measure Information:
Title
The total time within target sedation level
Description
Sedation level with RASS score is recorded every 4 hours during sedation. When target sedation was not obtained, sedation drug dosage changed and when adverse event needed to be treated, the sedation level is also recorded. The adjustment of sedation drug is recorded.
Time Frame
From sedation drug is used to weaning from sedation up to 28 days.
Secondary Outcome Measure Information:
Title
The dosage of sedation/analgesic drug
Description
Record the induced and maintained dosage of sedation/opioid analgesic drug. The total dosage of sedation/opioid analgesic drug. The added dosage of midazolam.
Time Frame
From sedation/analgesic drug is used to weaning from sedation/analgesic up to 28 days.
Title
Duration of mechanical ventilation
Description
The duration of mechanical ventilation is recorded.
Time Frame
From beginning to weaning from ventilation up to 28 days..
Title
Economic outcome
Description
The cost of sedation drug used is recorded. The cost of mechanical ventilation is recorded. The cost of ICU residency is recorded.
Time Frame
From admitted to ICU until ventilation and sedation stopped and participants discharged from ICU up to 28 days.
Title
Satisfactory of patients to ICU stay from admitted until discharged from ICU
Description
Evaluated the satisfactory of patients to ICU. Using scores including 0 to 10. 0 presents extremely dissatisfied and 10 presents extremely satisfied.
Time Frame
Assessed at time of 1 week participants discharged from ICU.
Title
Delirium
Description
Delirium is evaluated when daily sedation interruption is done during sedation. Delirium incidence is recorded using CAM-ICU. Treatment of delirium is recorded including drug,dosage and method of administration.
Time Frame
From sedation drug is used to weaning from sedation, up to 28 days.
Title
Vital signs
Description
Heart rate(HR),main arterial pressure(MAP),respiratory rate(RR),pulse saturate of oxygen(SPO2) are recorded every 4 hours. When sedation drug dosage changed and adverse events treated,the vital signs is also recorded. Gas blood analysis index is recorded when the daily interruption is done and when the SPO2 is less 90% or 10% decrease than normal.
Time Frame
From sedation drug is used to weaning from sedation, up to 28 days.
Title
Duration of ICU stay
Description
Record when participants discharged form ICU.
Time Frame
From date of admission until participants discharged from ICU up to 28 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ICU patients needing sedation 18 years or older mechanically ventilated for less than 96 hours prior to start of study drug. Exclusion Criteria: Trauma and burn patients as admitting diagnosis. Dialysis of all types. Pregnant or lactation. Neuromuscular blockade other than for intubation. Epidural or spinal analgesia. General anesthesia prior to or planned after the start of study drug infusion Serious central nervous system pathology(acute stroke, uncontrolled seizures,severe dementia). Acute hepatitis or severe liver disease (Child-Pugh class C). Unstable angina or acute myocardial infarction. Left ventricular ejection fraction less than 30%,heart rate less than 50/min. 11.Second or third degree heart block. 12.Allergy to the study drug. 13.Systolic blood pressure less than 90 mm Hg despite continuous infusions of 2 vasopressors before the start of study drug infusion. 14. Patients with renal insufficiency were randomized and treated; however, patients were discontinued if they required dialysis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Da W Wu, Doctor.
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Study Director
Facility Information:
Facility Name
Department ICU, Shandong university affiliated Qilu Hospital.
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Da W Wu, Doctor
Phone
13791122767
Email
wdw.55@163.com
First Name & Middle Initial & Last Name & Degree
Qian Zhai, Doctor

12. IPD Sharing Statement

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Safety and Efficacy of Combined Sedation With Midazolam and Dexmedetomidine in ICU Patients

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