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

NCT02080169 | Unknown Phase 4

• 1 other identifier: CMAqiluICU
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Intensive care unit; Mechanical ventilation; Combined sedation

Outcome Measures

Primary Outcomes (1)

• The total time within target sedation level

  1. Sedation level with RASS score is recorded every 4 hours during sedation. 2. When target sedation was not obtained, sedation drug dosage changed and when adverse event needed to be treated, the sedation level is also recorded. 3. The adjustment of sedation drug is recorded.

  From sedation drug is used to weaning from sedation up to 28 days.

Secondary Outcomes (7)

• The dosage of sedation/analgesic drug

  From sedation/analgesic drug is used to weaning from sedation/analgesic up to 28 days.

• Duration of mechanical ventilation

  From beginning to weaning from ventilation up to 28 days..

• Economic outcome

  From admitted to ICU until ventilation and sedation stopped and participants discharged from ICU up to 28 days.

• Satisfactory of patients to ICU stay from admitted until discharged from ICU

  Assessed at time of 1 week participants discharged from ICU.

• Delirium

  From sedation drug is used to weaning from sedation, up to 28 days.

Study Arms (3)

midazolam

EXPERIMENTAL

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.

Drug: midazolam; Drug: Fentanyl

Dexmedetomidine

EXPERIMENTAL

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.

Drug: Dexmedetomidine; Drug: Fentanyl

midazolam & dexmedetomidine

EXPERIMENTAL

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.

Drug: midazolam; Drug: Dexmedetomidine; Drug: Fentanyl

Interventions

midazolam DRUG

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.

Also known as: Liyuxi

midazolam; midazolam & dexmedetomidine

Dexmedetomidine DRUG

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.

Also known as: Yisi

Dexmedetomidine; midazolam & dexmedetomidine

Fentanyl DRUG

Fentanyl is used as analgesic drug in order to obtain the VAS \<3.

Dexmedetomidine; midazolam; midazolam & dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Chinese Medical Association: collaborator

Study Sites (1)

Department ICU, Shandong university affiliated Qilu Hospital.

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Midazolam; Dexmedetomidine; Fentanyl

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperidines

Study Officials

• Da W Wu, Doctor.

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intensive Care Unit

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: March 6, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 6, 2014

Record last verified: 2014-03

Locations

CN (1)