The Effect of Physostigmine on Cognitive Functioning in the Immediate Period After Sedation for Colonoscopy
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|ClinicalTrials.gov Identifier: NCT01121497|
Recruitment Status : Unknown
Verified April 2010 by Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : May 12, 2010
Last Update Posted : May 12, 2010
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Dysfunction||Drug: Physostigmine||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||July 2011|
Colonoscopy sedation with or without physostigmine
Intravenous bolus of physostigmine 1 mg, 3-5 minutes before completion of the colonoscopy procedure
- Cognitive functioning assessed by standard neuropsychological tests [ Time Frame: At time of hospital discharge following colonoscopy procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121497
|Contact: Benzion Beilin, MDfirstname.lastname@example.org|
|Hasharon Hospital, Rabin Medical Center|
|Petah Tiqva, Israel, 49372|
|Principal Investigator: Benzion Beilin, MD|
|Principal Investigator:||Bezion Beilin, MD||Hasharon Hospital, Rabin Medical Center|