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

NCT ID: NCT03102359

Last Updated: 2019-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-05

Study Completion Date

2019-12-31

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.

Detailed Description

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Conditions

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Liver Transplant; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Selective Head Cooling

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

Group Type EXPERIMENTAL

Cooling Helmet

Intervention Type DEVICE

Using cooling helmet for selective head cooling group and Selective Head Cooling and Dexmedetomidine group

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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Using dexmedetomidine at anesthesia induction and maintain until the end of the surgery

Selective Head Cooling and Dexmedetomidine

Using selective head cooling combined with dexmedetomidine as described before

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Using dexmedetomidine at anesthesia induction and maintain until the end of the surgery

Cooling Helmet

Intervention Type DEVICE

Using cooling helmet for selective head cooling group and Selective Head Cooling and Dexmedetomidine group

Control

No intervention in this group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dexmedetomidine

Using dexmedetomidine at anesthesia induction and maintain until the end of the surgery

Intervention Type DRUG

Cooling Helmet

Using cooling helmet for selective head cooling group and Selective Head Cooling and Dexmedetomidine group

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Huawei He

Postgraduate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ailin Luo, doctorate

Role: CONTACT

13507122565

Facility Contacts

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Lei Li, postgraduate

Role: primary

18627752156

Other Identifiers

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TJ-IRB20170201

Identifier Type: -

Identifier Source: org_study_id

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