Sugammadex and Cognitive Function
Effect of Sugammadex Versus Neostigmine/Atropine Combination on Cognitive Function After Elective Adult Surgery
1 other identifier
interventional
160
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 8, 2015
CompletedFirst Posted
Study publicly available on registry
April 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 13, 2020
April 1, 2020
5.3 years
April 8, 2015
April 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in the Mini-Mental State Evaluation test
Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Change in the clock-drawing test
Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Change in the Isaacs set test
Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Secondary Outcomes (1)
Time from reversal agent administration to extubation
After reversal agent administration
Study Arms (2)
Sugammadex
ACTIVE COMPARATORSugammadex is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery.
Neostigmine/atropine
ACTIVE COMPARATORNeostigmine combined to atropine is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery.
Interventions
Eligibility Criteria
You may qualify if:
- Patients aged \>40 years old
- ASA I-III
- Patients scheduled for elective surgery with general anaesthesia.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Attikon Hospitallead
Study Sites (1)
2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Athens, 12462, Greece
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Anesthesiology, 2nd Department of Anesthesiology, School of Medicine, University of Athens
Study Record Dates
First Submitted
April 8, 2015
First Posted
April 17, 2015
Study Start
September 1, 2010
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
April 13, 2020
Record last verified: 2020-04