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

Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cognitive Dysfunction

Intervention: Physostigmine (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Rabin Medical Center

Official(s) and/or principal investigator(s):
Bezion Beilin, MD, Principal Investigator, Affiliation: Hasharon Hospital, Rabin Medical Center

Overall contact:
Benzion Beilin, MD, Phone: 972-3-937-2469, Email: beilinb@clalit.org.il

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

Clinical Details

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

Primary outcome: Cognitive functioning assessed by standard neuropsychological tests

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.)

Locations and Contacts

Benzion Beilin, MD, Phone: 972-3-937-2469, Email: beilinb@clalit.org.il

Hasharon Hospital, Rabin Medical Center, Petah Tiqva 49372, Israel; Not yet recruiting
Benzion Beilin, MD, Principal Investigator
Additional Information

Starting date: July 2010
Last updated: May 11, 2010

Page last updated: August 23, 2015

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