Sugammadex and Cognitive Function

NCT ID: NCT02419352

Last Updated: 2020-04-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-12-31

Brief Summary

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Post operative cognitive dysfunction (POCD) is recognized as a frequent complication after both cardiac and non cardiac surgery, affecting approximately 1/3 of the patients. The aim of this study is to examine the possible effect of the novel reversal agent sugammadex versus neostigmine/ atropine combination on cognitive function of adult patients after elective surgery during the early post operative period as well as at discharge.

Detailed Description

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Conditions

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Post Operative Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sugammadex

Sugammadex is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery.

Group Type ACTIVE_COMPARATOR

Sugammadex

Intervention Type DRUG

Neostigmine/atropine

Neostigmine combined to atropine is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery.

Group Type ACTIVE_COMPARATOR

Neostigmine/atropine

Intervention Type DRUG

Interventions

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Sugammadex

Intervention Type DRUG

Neostigmine/atropine

Intervention Type DRUG

Other Intervention Names

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Bridion

Eligibility Criteria

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Inclusion Criteria

* Patients aged \>40 years old
* ASA I-III
* Patients scheduled for elective surgery with general anaesthesia.

Exclusion Criteria

* Neuro-, vascular-, orthopedic- or cardiac surgery
* Known psychiatric or disease of the CNS
* History of craniotomy
* Receiving tranquillisers or antidepressants on a regular basis pre-operatively
* Alcoholism or drug dependence
* History of stroke
* Refusal of patient
* Inability to read or write
* MMSE \< 22 pre-operatively
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Attikon Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chrysanthi Batistaki

Assistant Professor of Anesthesiology, 2nd Department of Anesthesiology, School of Medicine, University of Athens

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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331/21-9-10

Identifier Type: -

Identifier Source: org_study_id

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