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

Phase 4

Completed

• Conditions: Liver Transplantation
• Interventions: Drug: placebo control; Drug: Precedex

• Registration Number: NCT02245256
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-01
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-19
• Primary Completion: 2018-01-01
• Study Completion: 2018-02-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	placebo control	same infusion rate as experimental group (dexmedetomidine)
dexmedetomidine	Precedex	0.1mcg/kg/hr of dexmedetomidine infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Agree, Korea, Republic of