Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics

Govind Ballabh Pant Hospital

Status and phase: Unknown; Phase 4

Conditions: Hepatic Encephalopathy

Treatments: Drug: Midazolam; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01356121

5289617

Details and patient eligibility

About

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

Full description

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Midazolam

Active Comparator group

Description:

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

Treatment:

Drug: Midazolam

Propofol

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol

No Sedation

No Intervention group

Description:

No sedation given in this group