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

NCT ID: NCT02080169

Last Updated: 2014-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

midazolam

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.

Group Type: EXPERIMENTAL

midazolam

Intervention Type: 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.

Fentanyl

Intervention Type: DRUG

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

Dexmedetomidine

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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.

Fentanyl

Intervention Type: DRUG

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

midazolam & dexmedetomidine

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.

Group Type: EXPERIMENTAL

midazolam

Intervention Type: 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.

Dexmedetomidine

Intervention Type: 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.

Fentanyl

Intervention Type: DRUG

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

Interventions

midazolam

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

Dexmedetomidine

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

Fentanyl

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

Intervention Type: DRUG

Other Intervention Names

Liyuxi; Yisi

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Medical Association

NETWORK

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Qian Zhai

Intensive Care Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Da W Wu, Doctor.

Role: STUDY_DIRECTOR

Qilu Hospital of Shandong University

Locations

Department ICU, Shandong university affiliated Qilu Hospital.

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Da W Wu, Doctor

Role: primary

wdw.55@163.com

13791122767

Other Identifiers

CMAqiluICU

Identifier Type: -

Identifier Source: org_study_id