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

Cognitive Dysfunction Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01121497
• Other study ID #: 5759
• Status: Not yet recruiting
• Phase: N/A
• First received: May 9, 2010
• Last updated: May 11, 2010
• Start date: July 2010
• Est. completion date: July 2011

Study information

• Verified date: April 2010
• Source: Rabin Medical Center
• Contact: Benzion Beilin, MD
• Phone: 972-3-937-2469
• Email: beilinb[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction

Intervention

Drug:
• Physostigmine
Intravenous bolus of physostigmine 1 mg, 3-5 minutes before completion of the colonoscopy procedure

Locations

Country	Name	City	State
Israel	Hasharon Hospital, Rabin Medical Center	Petah Tiqva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive functioning assessed by standard neuropsychological tests		At time of hospital discharge following colonoscopy procedure	No