The Effect of Physostigmine on Cognitive Functioning in the Immediate Period After Sedation for Colonoscopy
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention |
|---|---|
|
Cognitive Dysfunction |
Drug: Physostigmine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
- Cognitive functioning assessed by standard neuropsychological tests [ Time Frame: At time of hospital discharge following colonoscopy procedure ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Physostigmine
Colonoscopy sedation with or without physostigmine
|
Drug: Physostigmine
Intravenous bolus of physostigmine 1 mg, 3-5 minutes before completion of the colonoscopy procedure
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.)
Contacts and Locations| Contact: Benzion Beilin, MD | 972-3-937-2469 | beilinb@clalit.org.il |
| Israel | |
| Hasharon Hospital, Rabin Medical Center | Not yet recruiting |
| Petah Tiqva, Israel, 49372 | |
| Principal Investigator: Benzion Beilin, MD | |
| Principal Investigator: | Bezion Beilin, MD | Hasharon Hospital, Rabin Medical Center |
More Information
No publications provided
| Responsible Party: | Prof. Benzion Beilin, Hasharon Hospital, Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT01121497 History of Changes |
| Other Study ID Numbers: | 5759 |
| Study First Received: | May 9, 2010 |
| Last Updated: | May 11, 2010 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Rabin Medical Center:
|
Sedation Cognitive decline Physostigmine Colonoscopy |
Additional relevant MeSH terms:
|
Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Physostigmine Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Miotics Autonomic Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013