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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01121497
First Posted: May 12, 2010
Last Update Posted: May 12, 2010
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.
Information provided by:
Rabin Medical Center
  Purpose
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 Intervention
Cognitive Dysfunction Drug: Physostigmine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

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

Estimated Enrollment: 160
Study Start Date: July 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
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
Contact: Benzion Beilin, MD 972-3-937-2469 beilinb@clalit.org.il

Locations
Israel
Hasharon Hospital, Rabin Medical Center Not yet recruiting
Petah Tiqva, Israel, 49372
Principal Investigator: Benzion Beilin, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Bezion Beilin, MD Hasharon Hospital, Rabin Medical Center
  More Information

Responsible Party: Prof. Benzion Beilin, Hasharon Hospital, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01121497     History of Changes
Other Study ID Numbers: 5759
First Submitted: May 9, 2010
First Posted: May 12, 2010
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:
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