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

NCT03102359 | Unknown Phase 2

• 1 other identifier: TJ-IRB20170201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• Postoperative minimal hepatic encephalopathy (MHE)

  Using PSE-Syndrom-Test

  14 days after surgery

Study Arms (4)

Selective Head Cooling

EXPERIMENTAL

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

Device: Cooling Helmet

Dexmedetomidine

EXPERIMENTAL

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

Selective Head Cooling and Dexmedetomidine

EXPERIMENTAL

Using selective head cooling combined with dexmedetomidine as described before

Drug: Dexmedetomidine; Device: Cooling Helmet

Control

NO INTERVENTION

No intervention in this group

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine; Selective Head Cooling and Dexmedetomidine

Cooling Helmet DEVICE

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

Selective Head Cooling; Selective Head Cooling and Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

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

Wuhan, Hubei, 430040, China

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Ailin Luo, doctorate

CONTACT

13507122565; alluo@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 5, 2017
• Study Start: April 5, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)