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

Huazhong University of Science and Technology

Status and phase: Unknown; Phase 2

Conditions: Liver Transplant; Complications

Treatments: Drug: Dexmedetomidine; Device: Cooling Helmet

Study type: Interventional

Funder types: Other

Identifiers

NCT03102359

TJ-IRB20170201

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

Selective Head Cooling

Experimental group

Description:

Participants received a cooling helmet filled with ice water mixture after an-esthesia induction until the end of the surgery.

Treatment:

Device: Cooling Helmet

Dexmedetomidine

Experimental group

Description:

Giving dexmedetomidine1μg/kg i.v for 10 minutes, then use computerized infusion pump at 0.5μg/kg.h until the end of the surgery.

Treatment:

Drug: Dexmedetomidine

Selective Head Cooling and Dexmedetomidine

Experimental group

Description:

Using selective head cooling combined with dexmedetomidine as described before

Treatment:

Device: Cooling Helmet

Drug: Dexmedetomidine

Control

No Intervention group

Description:

No intervention in this group