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

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ClinicalTrials.gov Identifier: NCT03102359
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Lei Li, 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.

Condition or disease Intervention/treatment Phase
Liver Transplant; Complications Drug: Dexmedetomidine Device: Cooling Helmet Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cerebral Protection Effect of Selective Head Cooling and Dexmedetomidine in Patients Undergoing Liver Transplantation
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Selective Head Cooling
Participants received a cooling helmet filled with ice water mixture after an-esthesia induction until the end of the surgery.
Device: Cooling Helmet
Using cooling helmet for selective head cooling group and Selective Head Cooling and Dexmedetomidine group

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

Experimental: Selective Head Cooling and Dexmedetomidine
Using selective head cooling combined with dexmedetomidine as described before
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

No Intervention: Control
No intervention in this group



Primary Outcome Measures :
  1. Postoperative minimal hepatic encephalopathy (MHE) [ Time Frame: 14 days after surgery ]
    Using PSE-Syndrom-Test



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102359


Contacts
Contact: Ailin Luo, doctorate 13507122565 alluo@tjh.tjmu.edu.cn

Locations
China, Hubei
Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430040
Contact: Lei Li, postgraduate    18627752156    535413900@qq.com   
Sponsors and Collaborators
Huazhong University of Science and Technology

Responsible Party: Lei Li, Postgraduate, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03102359     History of Changes
Other Study ID Numbers: TJ-IRB20170201
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action