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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-07-31

Brief Summary

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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

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Safety Issues

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Detailed Description

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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.

Conditions

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Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Physostigmine

Colonoscopy sedation with or without physostigmine

Group Type EXPERIMENTAL

Physostigmine

Intervention Type DRUG

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

Interventions

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Physostigmine

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

Intervention Type DRUG

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No