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

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245256
• Other study ID #: 1407-114-596
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2014
• Est. completion date: February 1, 2018

Study information

• Verified date: September 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: February 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Liver Transplantation

Intervention

Drug:
• Precedex
infusion of 0.1mcg/kg/hr of precedex
• placebo control
placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Agree

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Hospira, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analysis of the incidence of postoperative delirium in liver transplant patients in the ICU.	after August 25, 2014	1 week or transfer to ward, whichever comes first.
Secondary	analysis of the duration of postoperative delirium, ICU length of stay in liver transplant patients in the ICU.	after August 26, 2014	1 week or transfer to ward, whichever comes first.

External Links

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