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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01121497
Other study ID # 5759
Secondary ID
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


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
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