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Efficacy of Low-dose Dexmedetomidine to Prevent Delirium in Liver Transplant Patients

Perioperative Low-dose Dexmedetomidine Decreases Incidence of Delirium in Liver Transplant Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02245256
Enrollment
217
Registered
2014-09-19
Start date
2014-09-01
Completion date
2018-02-01
Last updated
2019-09-25

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

Conditions

Liver Transplantation

Keywords

delirium, incidence, dexmedetomidine

Brief summary

To test the effect of low-dose dexmedetomidine for lowering the incidence of postoperative delirium in liver transplant patients in the ICU. Single center prospective randomized placebo controlled clinical trial 0.1mcg/kg/hr of dexmedetomidine or equivalent amount of saline infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery. Outcomes will be assessed up to 1 week or transfer to ward, whichever comes first.

Interventions

infusion of 0.1mcg/kg/hr of precedex

DRUGplacebo control

placebo

Sponsors

Hospira, now a wholly owned subsidiary of Pfizer
CollaboratorINDUSTRY
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Adult patients (18years old or older) undergoing living-donor or deceased-donor liver transplantation

Exclusion criteria

* Pediatric patients (under 18 years) Pregnancy Patients who are unresponsive at baseline, who have neurologic deficits at baseline, or who are allergic to dexmedetomidine

Design outcomes

Primary

MeasureTime frameDescription
analysis of the incidence of postoperative delirium in liver transplant patients in the ICU.1 week or transfer to ward, whichever comes first.after August 25, 2014

Secondary

MeasureTime frameDescription
analysis of the duration of postoperative delirium, ICU length of stay in liver transplant patients in the ICU.1 week or transfer to ward, whichever comes first.after August 26, 2014

Countries

South Korea

Outcome results

None listed

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