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

Phase 2

• Conditions: Liver Transplant; Complications
• Interventions: Device: Cooling Helmet; Drug: Dexmedetomidine

• Registration Number: NCT03102359
• Lead Sponsor: Huazhong University of Science and Technology

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-03-30
• Study Start: 2017-04-05
• Study First Posted: 2017-04-05
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-25
• Last Update Posted: 2019-05-29
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Selective Head Cooling	Cooling Helmet	Participants received a cooling helmet filled with ice water mixture after an-esthesia induction until the end of the surgery.
Dexmedetomidine	Dexmedetomidine	Giving dexmedetomidine1μg/kg i.v for 10 minutes, then use computerized infusion pump at 0.5μg/kg.h until the end of the surgery.
Selective Head Cooling and Dexmedetomidine	Cooling Helmet	Using selective head cooling combined with dexmedetomidine as described before
Selective Head Cooling and Dexmedetomidine	Dexmedetomidine	Using selective head cooling combined with dexmedetomidine as described before

Primary Outcome Measures

Name	Time	Method
Postoperative minimal hepatic encephalopathy (MHE)	14 days after surgery	Using PSE-Syndrom-Test

Trial Locations

Locations (1)

Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China