Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Physostigmine on Cognitive Functioning in the Immediate Period After Sedation for Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01121497
Recruitment Status : Unknown
Verified April 2010 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 12, 2010
Last Update Posted : May 12, 2010
Sponsor:
Information provided by:
Rabin Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine whether the administration of physostigmine in combination with sedation for colonoscopy can minimize the cognitive decline at the time of hospital discharge

Condition or disease Intervention/treatment Phase
Cognitive Dysfunction Drug: Physostigmine Not Applicable

Detailed Description:

Physostigmine, a tertiary cholinesterase inhibitor, which prevents the breakdown of ACh by inhibiting the enzyme acetylcholinesterase (AChE), crosses the blood-brain barrier (BBB), and elevates brain ACh levels. Physostigmine has been shown to improve attention, and performance in working memory. It has also been shown to produce analgesia following systemic or central administration.

Patients undergoing colonoscopy under sedation of propofol and fentanyl show cognitive decline in the immediate period following the procedure. In this study, half the patients will receive physostigmine in combination with the sedation, and their cognitive functioning at the time of hospital discharge will be assessed by standard neuropsychological tests, and compared to that of patients without physostigmine.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : July 2010
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Physostigmine
Colonoscopy sedation with or without physostigmine
 Drug: Physostigmine
Intravenous bolus of physostigmine 1 mg, 3-5 minutes before completion of the colonoscopy procedure


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Cognitive functioning assessed by standard neuropsychological tests [ Time Frame: At time of hospital discharge following colonoscopy procedure ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over18 years old
  • ASA I-III
  • Fluency in Hebrew, Russian, or Arabic
  • Absence of serious hearing or vision impairment

Exclusion Criteria:

  • History of head trauma, neurological diseases, alcoholism, drug abuse, consumption of psychotropic drugs or antidepressants
  • Heart failure (NYHA > 3)
  • Liver failure
  • Respiratory problems (asthma, etc.)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121497


Contacts
Layout table for location contacts
Contact: Benzion Beilin, MD 972-3-937-2469 beilinb@clalit.org.il

Locations
Layout table for location information
Israel
Hasharon Hospital, Rabin Medical Center
Petah Tiqva, Israel, 49372
Principal Investigator: Benzion Beilin, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Bezion Beilin, MD Hasharon Hospital, Rabin Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Prof. Benzion Beilin, Hasharon Hospital, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01121497    
Other Study ID Numbers: 5759
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: May 12, 2010
Last Verified: April 2010
Keywords provided by Rabin Medical Center:
Sedation
Cognitive decline
Physostigmine
Colonoscopy
Additional relevant MeSH terms:
Layout table for MeSH terms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Physostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Miotics
Autonomic Agents
Peripheral Nervous System Agents