Sugammadex and Cognitive Function

Post Operative Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419352
• Other study ID #: 331/21-9-10
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: December 2015

Study information

• Verified date: April 2020
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Post Operative Cognitive Dysfunction

Intervention

Drug:
• Sugammadex

• Neostigmine/atropine

Locations

Country	Name	City	State
Greece	2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Mini-Mental State Evaluation test		Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Primary	Change in the clock-drawing test		Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Primary	Change in the Isaacs set test		Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Secondary	Time from reversal agent administration to extubation		After reversal agent administration