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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01121497
First received: May 9, 2010
Last updated: May 11, 2010
Last verified: April 2010
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Prof. Benzion Beilin, Hasharon Hospital, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01121497     History of Changes
Other Study ID Numbers: 5759
Study First Received: May 9, 2010
Last Updated: May 11, 2010
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
Sedation
Cognitive decline
Physostigmine
Colonoscopy

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Physostigmine
Autonomic Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Miotics
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014