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

NCT02080169 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2014-03-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Chinese Medical Association

    collaborator NETWORK

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Da W Wu, Doctor. · Qilu Hospital of Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02080169 on ClinicalTrials.gov