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OpenTrials
Completed

NCT Number: NCT02245256

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

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.

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Key information

Conditions

Liver Transplantation Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, Agree, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Precedex

Drug

infusion of 0.1mcg/kg/hr of precedex

Placebo Control

Drug

placebo

Other names: 0.9% saline

Primary outcomes

  1. 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

  1. analysis of the duration of postoperative delirium, ICU length of stay in liver transplant patients in the ICU.

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

    after August 26, 2014

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 19, 2014
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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