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

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Transplant; Complications

Intervention / Treatment
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* Drug: Dexmedetomidine
* Device: Cooling Helmet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selective Head Cooling<br>Participants received a cooling helmet filled with ice water mixture after an-esthesia induction until the end of the surgery. | Device: Cooling Helmet<br>* Using cooling helmet for selective head cooling group and Selective Head Cooling and Dexmedetomidine group<br>|
| Experimental: Dexmedetomidine<br>Giving dexmedetomidine1μg/kg i.v for 10 minutes, then use computerized infusion pump at 0.5μg/kg.h until the end of the surgery. | Drug: Dexmedetomidine<br>* Using dexmedetomidine at anesthesia induction and maintain until the end of the surgery<br>|
| Experimental: Selective Head Cooling and Dexmedetomidine<br>Using selective head cooling combined with dexmedetomidine as described before | Drug: Dexmedetomidine<br>* Using dexmedetomidine at anesthesia induction and maintain until the end of the surgery<br>Device: Cooling Helmet<br>* Using cooling helmet for selective head cooling group and Selective Head Cooling and Dexmedetomidine group<br>|
| No Intervention: Control<br>No intervention in this group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative minimal hepatic encephalopathy (MHE) | Using PSE-Syndrom-Test | 14 days after surgery |