Sugammadex and Cognitive Function

Attikon University Hospital

Status: Completed

Conditions: Post Operative Cognitive Dysfunction

Treatments: Drug: Neostigmine/atropine; Drug: Sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT02419352

331/21-9-10

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Sugammadex

Active Comparator group

Description:

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

Treatment:

Drug: Sugammadex

Neostigmine/atropine

Active Comparator group

Description:

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

Treatment:

Drug: Neostigmine/atropine