Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients

Cirrhosis Clinical Trial

Official title:

Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141036
• Other study ID #: 006-08
• Secondary ID: 006-08ziv
• Status: Completed
• Phase: N/A
• First received: June 8, 2010
• Last updated: June 9, 2010
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: June 2010
• Source: Ziv Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Upper GI endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. The purpose of this study is to compare propofol to midazolam for sedation in patients with chronic liver disease undergoing diagnostic upper GI endoscopy.

Description:

Background : Upper GI endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. AIM: The purpose of this study is to compare propofol to midazolam for sedation in patients with chronic liver disease undergoing diagnostic upper GI endoscopy. Methods: 60 outpatients who has known chronic liver disease (Child-Pugh class A or B) (cirrhosis) and are undergoing variceal screening will be randomized to receive propofol or midazolam for sedation. Administration of sedation was performed by a anesthesist. Outcome measures studied are induction and recovery times, efficacy and safety of sedation, patient satisfaction, and return to baseline function and subclinical hepatic encephalopathy (number connection test), and saturation of oxygen. expected results: The mean time to achieve adequate sedation will be shorter for for the propofol group in comparison to midazolam group. The level of sedation achieved by the propofol group will be greater. Time to full recovery will be faster in the propofol group. Propofol do not exacerbate subclinical hepatic encephalopathy as compared to midazolam. patients receiving propofol will express greater overall mean satisfaction with the quality of their sedation at the time of discharge. Conclusions: Propofol sedation is expected not to exacerbate subclinical hepatic encephalopathy in cirrhotics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Known chronic liver disease (Child-Pugh class A or B) 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:

• Exclusion criteria will include the following:

• known allergy or adverse reaction to sedative or component thereof

• patients with known significant respiratory disease or airway abnormality)

• active neurological impairment including clinically detectable hepatic encephalopathy

• advanced or decompensated liver disease ( CP score >10, MELD >24) (Child-Pugh class C)

• active alcohol consumption or illicit drug abuse

• active prescription for sedation or narcotics

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cirrhosis

Intervention

Drug:
• propofol
Propofol will be initiated with a 30-50 mg 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.
• Midazolam
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

Locations

Country	Name	City	State
Israel	Ziv medical center liver unit	Safed, Israel

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exacerbation of hepatic encephalopathy			No
Secondary	Recovery time, time to discharge			No