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Clinical Trials/NCT02245256
NCT02245256
Completed
Phase 4

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

Seoul National University Hospital1 site in 1 country217 target enrollmentSeptember 1, 2014

Overview

Phase
Phase 4
Intervention
placebo control
Conditions
Liver Transplantation
Sponsor
Seoul National University Hospital
Enrollment
217
Locations
1
Primary Endpoint
analysis of the incidence of postoperative delirium in liver transplant patients in the ICU.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2014
End Date
February 1, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ho Geol Ryu

assistant professor

Seoul National University Hospital

Eligibility Criteria

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

Arms & Interventions

Normal saline

same infusion rate as experimental group (dexmedetomidine)

Intervention: placebo control

dexmedetomidine

0.1mcg/kg/hr of dexmedetomidine infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery.

Intervention: Precedex

Outcomes

Primary Outcomes

analysis of the incidence of postoperative delirium in liver transplant patients in the ICU.

Time Frame: 1 week or transfer to ward, whichever comes first.

after August 25, 2014

Secondary Outcomes

  • 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.)

Study Sites (1)

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