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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01121497

Enrollment

160

Registered

2010-05-12

Start date

2010-07-31

Completion date

2011-07-31

Last updated

2010-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction

Keywords

Sedation, Cognitive decline, Physostigmine, Colonoscopy

Brief 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

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.

Interventions

DRUGPhysostigmine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.)

Design outcomes

Primary

Measure	Time frame
Cognitive functioning assessed by standard neuropsychological tests	At time of hospital discharge following colonoscopy procedure

Countries

Israel

Contacts

Primary ContactBenzion Beilin, MD

beilinb@clalit.org.il972-3-937-2469

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026