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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Liver Transplantation

Treatments: Drug: Precedex; Drug: placebo control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02245256

1407-114-596

Details and patient eligibility

About

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.

Enrollment: 217 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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217 participants in 2 patient groups, including a placebo group

Normal saline

Placebo Comparator group

Description:

same infusion rate as experimental group (dexmedetomidine)

Treatment:

Drug: placebo control

dexmedetomidine

Experimental group

Description:

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

Treatment:

Drug: Precedex