NCT01121497

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 12, 2010

Status Verified

April 1, 2010

Enrollment Period

1 year

First QC Date

May 9, 2010

Last Update Submit

May 11, 2010

Conditions

Cognitive Dysfunction

Keywords

SedationCognitive declinePhysostigmineColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Cognitive functioning assessed by standard neuropsychological tests

    At time of hospital discharge following colonoscopy procedure

Study Arms (1)

Physostigmine

EXPERIMENTAL

Colonoscopy sedation with or without physostigmine

Drug: Physostigmine

Interventions

PhysostigmineDRUG

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

Physostigmine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over18 years old
  • ASA I-III
  • Fluency in Hebrew, Russian, or Arabic
  • Absence of serious hearing or vision impairment

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasharon Hospital, Rabin Medical Center

Petah Tikva, 49372, Israel

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Physostigmine

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylcarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Bezion Beilin, MD

    Hasharon Hospital, Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benzion Beilin, MD

CONTACT

972-3-937-2469beilinb@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2010

First Posted

May 12, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 12, 2010

Record last verified: 2010-04

Locations

IL(1)