Clinical trial NCT01141036: Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients
Official title: Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Keywords: Propofol
Midazolam
sedation
cirrhosis
endoscopy
recovery time
efficacy and safety of sedation
patient satisfaction
return to baseline function
saturation of oxygen
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2010-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Exacerbation of hepatic encephalopathy
Secondary outcomes:
measure: Recovery time, time to discharge
Other outcomes:
Locations:
city: Safed, Israel
country: Israel
facility: Ziv medical center liver unit
Study officials:
References: