Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics

Study Overview
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Brief Summary
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To compare effects of sedation for upper gastrointestinal endoscopy with propofol and midazolam on psychometric tests and critical flicker frequency (CFF) in cirrhotics

Detailed Description
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Upper GI Endoscopy is routinely performed in patients with chronic liver disease to screen for complications related to portal hypertension such as esophageal and gastric varices and portal gastropathy. Sedation is frequently administered to facilitate patient tolerance.Patients with hepatic dysfunction who undergo endoscopy are at increased risk for complications related to sedation.Propofol has a favorable pharmacokinetic profile in comparison with benzodiazepines and opioids, which makes it especially appropriate for sedation in endoscopy.In previous studies cognitive functions were assessed by various paper and pencil tests. However learning affects the paper and pencil tests if repeated at short interval of time.CFF analysis was found to be sensitive and objective in the quantification of low-grade HE, and there is a significant correlation between CFF and the portosystemic encephalopathy syndrome (PHES) battery.Considering this, we designed a prospective randomized controlled study with cirrhotic outpatients to compare effects of sedation for upper gastrointestinal endoscopy with propofol versus midazolam on psychometric tests and critical flicker frequency in cirrhotics

Official Title
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Randomized Controlled Trial Comparing Effects of Sedation for Upper Gastrointestinal Endoscopy With Propofol Versus Midazolam on Psychometric Tests and Critical Flicker Frequency in Cirrhotics

Conditions
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Hepatic Encephalopathy

Intervention / Treatment
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* Drug: Propofol
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known chronic liver disease (Child-Pugh class A , B or C ) who presented for upper GI endoscopy for routine variceal screening. The diagnosis of liver disease will be based on available past history, serological testing, radiological imaging, and liver histology when available. Staging of cirrhosis will be determined by MELD score and by Child-Pugh score . All patients will complete a standard preprocedure history and physical examination to establish current degree of encephalopathy and ascites. Exclusion Criteria: Active GI bleeding Overt encephalopathy Active alcohol intake during the past 6 weeks Significant co morbid illness such as heart, respiratory, or renal failure and any neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies. Patients with known allergy to sedative hepatocellular carcinoma Previous TIPS or shunt surgery, Patients on psychoactive drugs, such as antidepressants or sedatives Patients with an American Society of Anesthesiology (ASA) physical status of class IV or V Patients with visual or mental impairment who will unable to complete the psychometric testing or CFF

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midazolam<br>Midazolam (0.5-1.0 mg) will be administered in a similar fashion with incremental dosing at intervals of approximately 1-3 min until a level of sedation will be achieved | Drug: Midazolam<br>* Midazolam (0.5-1.0 mg) will be administered in a similar fashion with incremental dosing at intervals of approximately 1-3 min until a level of sedation will be achieved<br>* Other names: Midazolaam;|
| Active Comparator: Propofol<br>Propofol will be initiated with a 0.5-1 mg/kg i.v. bolus followed by repeated 10-20 mg doses at variable intervals (approximately 15 s, at the discretion of the endoscopist/nurse) until an appropriate level of sedation will be achieved. | Drug: Propofol<br>* Propofol will be initiated with a .5-1 mg/kg i.v. bolus followed by repeated 10-20 mg doses at variable intervals (approximately 15 s, at the discretion of the endoscopist/nurse) until an appropriate level of sedation will be achieved.<br>|
| No Intervention: No Sedation<br>No sedation given in this group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbation of hepatic encephalopathy |  | 2 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery time |  | 2 hr | 
| Time to discharge |  | 2 hr |