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

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Clalit Health Services

Status

Unknown

Conditions

Cognitive Dysfunction

Treatments

Drug: Physostigmine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

160 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

160 participants in 1 patient group

Physostigmine
Experimental group
Description:
Colonoscopy sedation with or without physostigmine
Treatment:
Drug: Physostigmine

Trial contacts and locations

1

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Central trial contact

Benzion Beilin, MD

Data sourced from clinicaltrials.gov

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