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

Primary Purpose

Cognitive Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Physostigmine
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Dysfunction focused on measuring Sedation, Cognitive decline, Physostigmine, Colonoscopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Hasharon Hospital, Rabin Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physostigmine

Arm Description

Colonoscopy sedation with or without physostigmine

Outcomes

Primary Outcome Measures

Cognitive functioning assessed by standard neuropsychological tests

Secondary Outcome Measures

Full Information

First Posted
May 9, 2010
Last Updated
May 11, 2010
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01121497
Brief Title
The Effect of Physostigmine on Cognitive Functioning in the Immediate Period After Sedation for Colonoscopy
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction
Keywords
Sedation, Cognitive decline, Physostigmine, Colonoscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physostigmine
Arm Type
Experimental
Arm Description
Colonoscopy sedation with or without physostigmine
Intervention Type
Drug
Intervention Name(s)
Physostigmine
Intervention Description
Intravenous bolus of physostigmine 1 mg, 3-5 minutes before completion of the colonoscopy procedure
Primary Outcome Measure Information:
Title
Cognitive functioning assessed by standard neuropsychological tests
Time Frame
At time of hospital discharge following colonoscopy procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benzion Beilin, MD
Phone
972-3-937-2469
Email
beilinb@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bezion Beilin, MD
Organizational Affiliation
Hasharon Hospital, Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasharon Hospital, Rabin Medical Center
City
Petah Tiqva
ZIP/Postal Code
49372
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benzion Beilin, MD

12. IPD Sharing Statement

Learn more about this trial

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

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