Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Govind Ballabh Pant Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT01356121
First received: May 16, 2011
Last updated: May 17, 2011
Last verified: March 2011

May 16, 2011
May 17, 2011
November 2010
June 2011   (final data collection date for primary outcome measure)
Exacerbation of hepatic encephalopathy [ Time Frame: 2 hr ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01356121 on ClinicalTrials.gov Archive Site
  • Recovery time [ Time Frame: 2 hr ] [ Designated as safety issue: No ]
  • Time to discharge [ Time Frame: 2 hr ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics
Randomized Controlled Trial Comparing Effects of Sedation for Upper Gastrointestinal Endoscopy With Propofol Versus Midazolam on Psychometric Tests and Critical Flicker Frequency in Cirrhotics

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

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hepatic Encephalopathy
  • Drug: Propofol
    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.
    Other Name: Propofol
  • Drug: 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
    Other Name: Midazolaam
  • Active Comparator: 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
    Intervention: Drug: Midazolam
  • Active Comparator: Propofol
    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.
    Intervention: Drug: Propofol
  • No Intervention: No Sedation
    No sedation given in this group
Agrawal A, Sharma BC, Sharma P, Uppal R, Sarin SK. Randomized controlled trial for endoscopy with propofol versus midazolam on psychometric tests and critical flicker frequency in people with cirrhosis. J Gastroenterol Hepatol. 2012 Nov;27(11):1726-32. doi: 10.1111/j.1440-1746.2012.07231.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
July 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Barjesh C Sharma, MD,DM 9718599203 drbcsharma@hotmail.com
India
 
NCT01356121
5289617
Yes
Prof Barjesh Chander Sharma, G B Pant Hospital New Delhi 110002
Govind Ballabh Pant Hospital
Not Provided
Principal Investigator: Barjesh C Sharma, MD,DM Govind Ballabh Pant Hospital
Govind Ballabh Pant Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP