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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
History of Changes
  Purpose

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


Condition Intervention Phase
Hepatic Encephalopathy
 Drug: Propofol
Drug: Midazolam
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Effects of Sedation for Upper Gastrointestinal Endoscopy With Propofol Versus Midazolam on Psychometric Tests and Critical Flicker Frequency in Cirrhotics

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:
  • Exacerbation of hepatic encephalopathy [ Time Frame: 2 hr ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recovery time [ Time Frame: 2 hr ] [ Designated as safety issue: No ]
  • Time to discharge [ Time Frame: 2 hr ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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: 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.
 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
No Intervention: No Sedation
No sedation given in this group

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356121

Contacts
Contact: Barjesh C Sharma, MD,DM 9718599203 drbcsharma@hotmail.com

Locations
India
Prof Barjesh Chander Sharma Recruiting
New Delhi, Delhi, India, 110002
Contact: Barjesh C Sharma, MD,DM     9718599203     drbcsharma@hotmail.com    
Contact: Amit Agrawal, MD     9718599214     amit_04_dr@yahoo.com    
Principal Investigator: Barjesh C Sharma, MD,DM            
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Investigators
Principal Investigator: Barjesh C Sharma, MD,DM Govind Ballabh Pant Hospital
  More Information

No publications provided by Govind Ballabh Pant Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof Barjesh Chander Sharma, G B Pant Hospital New Delhi 110002
ClinicalTrials.gov Identifier: NCT01356121     History of Changes
Other Study ID Numbers: 5289617
Study First Received: May 16, 2011
Last Updated: May 17, 2011
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Hepatic Encephalopathy
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Midazolam
Propofol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013