Brain Protection Effect of Selective Head Cooling and Dexmedetomidine in Patients Undergoing Liver Transplantation

Liver Transplant; Complications Clinical Trial

Official title:

Cerebral Protection Effect of Selective Head Cooling and Dexmedetomidine in Patients Undergoing Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03102359
• Other study ID #: TJ-IRB20170201
• Status: Recruiting
• Phase: Phase 2
• Start date: April 5, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2019
• Source: Huazhong University of Science and Technology
• Contact: Ailin Luo, doctorate
• Phone: 13507122565
• Email: alluo[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators investigated in the present study whether selective head cooling and dexmedetomidine has an effect on cerebral oxygenation during liver transplantation and has cerebral protective effect in patients undergoing liver transplantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Scheduled for OLT, selected from the Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China.

• Sign the informed consent

Exclusion Criteria:

• The patients with a history of neurological or psychiatric disorders which impair cognitive processes, including previously established de-mentia, stroke, schizophrenia and depression were excluded from the study.

• Patients diagnosed with hepatic encephalopathy or had a low Mini-Mental State Examination (MMSE) score (below 24) preoperatively.

• With concurrent diseases such as renal insufficiency, diabetes mellitus were also excluded.

• Patients were excluded if severe reperfusion syn-drome (mean arterial pressure below 60mmHg sustained over 15minutes) occurred perioperatively.

Related Conditions & MeSH terms

• Liver Transplant; Complications

Intervention

Drug:
• Dexmedetomidine
Using dexmedetomidine at anesthesia induction and maintain until the end of the surgery

Device:
• Cooling Helmet
Using cooling helmet for selective head cooling group and Selective Head Cooling and Dexmedetomidine group

Locations

Country	Name	City	State
China	Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative minimal hepatic encephalopathy (MHE)	Using PSE-Syndrom-Test	14 days after surgery