NCT02080169

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-03-06
• Last updated: 2014-03-06

Locations

1 site across 1 country: China