Back to resultsSugammadex and Cognitive Function
Primary Purpose
Post Operative Cognitive Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Sugammadex
Neostigmine/atropine
Sponsored by
About this trial
This is an interventional screening trial for Post Operative Cognitive Dysfunction focused on measuring Cognitive function
Eligibility Criteria
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
Sites / Locations
- 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sugammadex
Neostigmine/atropine
Arm Description
Sugammadex is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery.
Neostigmine combined to atropine is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery.
Outcomes
Primary Outcome Measures
Change in the Mini-Mental State Evaluation test
Change in the clock-drawing test
Change in the Isaacs set test
Secondary Outcome Measures
Time from reversal agent administration to extubation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02419352
Brief Title
Sugammadex and Cognitive Function
Official Title
Effect of Sugammadex Versus Neostigmine/Atropine Combination on Cognitive Function After Elective Adult Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Cognitive Dysfunction
Keywords
Cognitive function
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugammadex
Arm Type
Active Comparator
Arm Description
Sugammadex is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery.
Arm Title
Neostigmine/atropine
Arm Type
Active Comparator
Arm Description
Neostigmine combined to atropine is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery.
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
Bridion
Intervention Type
Drug
Intervention Name(s)
Neostigmine/atropine
Primary Outcome Measure Information:
Title
Change in the Mini-Mental State Evaluation test
Time Frame
Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Title
Change in the clock-drawing test
Time Frame
Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Title
Change in the Isaacs set test
Time Frame
Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Secondary Outcome Measure Information:
Title
Time from reversal agent administration to extubation
Time Frame
After reversal agent administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
City
Athens
ZIP/Postal Code
12462
Country
Greece
12. IPD Sharing Statement
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Sugammadex and Cognitive Function
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