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Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics

Primary Purpose

Hepatic Encephalopathy

Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Propofol
Midazolam
Sponsored by
Govind Ballabh Pant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Prof Barjesh Chander SharmaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Midazolam

Propofol

No Sedation

Arm 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

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.

No sedation given in this group

Outcomes

Primary Outcome Measures

Exacerbation of hepatic encephalopathy

Secondary Outcome Measures

Recovery time
Time to discharge

Full Information

First Posted
May 16, 2011
Last Updated
May 17, 2011
Sponsor
Govind Ballabh Pant Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01356121
Brief Title
Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Govind Ballabh Pant Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Midazolam
Arm Type
Active Comparator
Arm 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
Arm Title
Propofol
Arm Type
Active Comparator
Arm 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.
Arm Title
No Sedation
Arm Type
No Intervention
Arm Description
No sedation given in this group
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Midazolaam
Intervention 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
Primary Outcome Measure Information:
Title
Exacerbation of hepatic encephalopathy
Time Frame
2 hr
Secondary Outcome Measure Information:
Title
Recovery time
Time Frame
2 hr
Title
Time to discharge
Time Frame
2 hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barjesh C Sharma, MD,DM
Phone
9718599203
Email
drbcsharma@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barjesh C Sharma, MD,DM
Organizational Affiliation
Govind Ballabh Pant Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof Barjesh Chander Sharma
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barjesh C Sharma, MD,DM
Phone
9718599203
Email
drbcsharma@hotmail.com
First Name & Middle Initial & Last Name & Degree
Amit Agrawal, MD
Phone
9718599214
Email
amit_04_dr@yahoo.com
First Name & Middle Initial & Last Name & Degree
Barjesh C Sharma, MD,DM

12. IPD Sharing Statement

Citations:
PubMed Identifier
22861074
Citation
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.
Results Reference
derived

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Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics

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