Treatment of Hepatic Encephalopathy With Flumazenil and Change in Cortical GABA Levels in MRS
Hepatic Encephalopathy, Liver Cirrhosis
About this trial
This is an interventional basic science trial for Hepatic Encephalopathy focused on measuring hepatic encephalopathy, flumazenil, liver cirrhosis
Eligibility Criteria
Inclusion Criteria:
- Age: 18 and older
- ICD-9 diagnosis of hepatic encephalopathy
- Ability to feel comfortable in confined areas (like MRI)
- Ability to provide informed consent
- Speaks fluent English without any communication barriers
- Reliable family member or friend able to stay with participant during abstinence from HE medication prior to visit.
Exclusion Criteria:
- Current DSM-IV-R diagnosis of Alcohol or Other Drug Abuse or Dependence
- Positive screen for alcohol abuse as determined by the CAGE questionnaire
- Positive urine toxicity screen for benzodiazepine medications or illicit drugs
- History of long-term use of benzodiazepine medications
- Current use of non-benzodiazepine agonist medications
- History of Panic Disorder
- History of any Psychotic Disorder
- History of seizures and/or Seizure Disorder
- History of dysrhythmia, cardiovascular collapse, or recent head trauma
- History of side effects from anticholinergic medications
- History of cyclic antidepressant overdose or poisoning
- Pregnant or nursing
- Resides in nursing home or other long-term care facility
Sites / Locations
- Yale Psychological Medicine Research Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Flumazenil
Saline
A priming dose bolus of 0.4 mg of flumazenil will be administered intravenously (Minute 0). At this time the 1H-MRS scan will begin. Over the next 6 minutes, a drip infusion of flumazenil will be administered to the patient at a rate of 0.1 mg flumazenil per minute for a total of 7 doses during the scan. Total dose will be 1.0 mg.
A priming dose bolus of 0.4 mg of placebo will be administered intravenously (Minute 0). At this time the 1H-MRS scan will begin. Over the next 6 minutes, a drip infusion of placebo mixed with saline will be administered to the patient at a rate of 0.1 mg per minute for a total of 7 doses during the scan. Total dose will be 1.0 mg.