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Safety Study of Dexmedetomidine in Septic Patients

The Effective Dose of Dexmedetomidine for Moderate Sedation of Adult Intubated Septic Patients in the ICU.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01976754
Enrollment
40
Registered
2013-11-06
Start date
2013-09-30
Completion date
2015-07-31
Last updated
2022-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation, Sepsis

Brief summary

Septic patients in Intensive Care Unit always need mechanical ventilation and conscious-sedation. But the recommended dose 0.2-0.7μg/kg/h could not run well because of wide range. The purpose of this study is to find the effective dose of dexmedetomidine adult septic patients of mechanical ventilation .

Detailed description

Inclusion Criteria: Age: between 18 years mechanical ventilation RASS≥2 A diagnosis of sepsis within 48 hours Exclusion Criteria: Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle relaxant users Primary Outcome Measures: Dose of dexmedetomidine Secondary Outcome Measures: RASS score Requirement for rescue intervention, RASS will be recorded per hour.

Interventions

DRUGDexmedetomidine

Septic patients are randomly received 1 of 6 doses( 0.2,0.3,0.4,0.5,0.6,0.7μg/kg/h) dexmedetomidine.

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* intubated patients RASS≥2 A diagnosis of sepsis within 48h

Exclusion criteria

* Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle relaxant users

Design outcomes

Primary

MeasureTime frame
Dose of dexmedetomidine12 hours

Secondary

MeasureTime frame
RASS score Requirement for rescue intervention, RASS will be recorded per hour.1 hour

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026