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

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

Study Overview

• Status: Unknown
• Conditions: Cognitive Dysfunction
• Intervention / Treatment: Drug: Physostigmine

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benzion Beilin, MD; Phone Number: 972-3-937-2469; Email: beilinb@clalit.org.il

Study Locations

• Israel
  • Petah Tiqva, Israel, 49372
    • Hasharon Hospital, Rabin Medical Center
    • Principal Investigator: Benzion Beilin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cognitive functioning assessed by standard neuropsychological tests	At time of hospital discharge following colonoscopy procedure

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Bezion Beilin, MD, Hasharon Hospital, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: May 9, 2010
• First Submitted That Met QC Criteria: May 11, 2010
• First Posted (Estimate): May 12, 2010

Study Record Updates

• Last Update Posted (Estimate): May 12, 2010
• Last Update Submitted That Met QC Criteria: May 11, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Cognitive decline; Colonoscopy; Sedation; Physostigmine
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Miotics; Physostigmine
• Other Study ID Numbers: 5759