Sugammadex and Cognitive Function

April 10, 2020 updated by: Chrysanthi Batistaki, Attikon Hospital

Effect of Sugammadex Versus Neostigmine/Atropine Combination on Cognitive Function After Elective Adult Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 12462
        • 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sugammadex
Sugammadex is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery.
Drug: Sugammadex
Other Names:
  • Bridion
Active Comparator: Neostigmine/atropine
Neostigmine combined to atropine is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery.
Drug: Neostigmine/atropine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the Mini-Mental State Evaluation test
Time Frame: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Change in the clock-drawing test
Time Frame: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Change in the Isaacs set test
Time Frame: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from reversal agent administration to extubation
Time Frame: After reversal agent administration
After reversal agent administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Attikon Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 331/21-9-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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