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Risk Prediction of Dexmedetomidine-associated Hemodynamic Instability

NCT03285087 · Status: SUSPENDED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2021-01-14

No results posted yet for this study

Summary

Hypotension and bradycardia have been commonly associated with dexmedetomidine therapy, occurring in 13% to 68% and 1% to 42% of patients, respectively. The variability in reported incidence may be partially attributed to inconsistent definitions and study populations. The significance of this hemodynamic instability is not only highlighted by its high incidence but also the need for corrective interventions. In one study, hemodynamic instability requiring clinical intervention occurred in nearly one third of ICU patients receiving dexmedetomidine. Moreover, patients who experienced dexmedetomidine-associated hypotension had a higher mortality rate than those who did not.

Conditions

  • Sedation

Interventions

DRUG

DEX 0.2 μg/kg/h.

DEX 0.2 μg/kg/h. The dose will be increased in 0.1 μg/kg/h increments to achieve target Richmond Agitation Sedation Scale (RASS) levels of -2 to zero and with a maximum dose of 1.4 μg/kg/h for 24 hours.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Hala S Abdelghaffar, MD · Professor of anesthesia, faculty of medicine, Assiut university, Egypt

  • Hala S Abdelghaffar, MD · Professor of anesthesia, faculty of medicine, Assiut university, Assiut, Egypy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Egypt

Study Locations

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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 NCT03285087 on ClinicalTrials.gov