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Completed

NCT Number: NCT02419352

Sugammadex and Cognitive Function

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.

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Key information

Conditions

Post Operative Cognitive Dysfunction

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Athens, 12462, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

Other names: Bridion

Neostigmine/atropine

Drug

Primary outcomes

  1. Change in the Mini-Mental State Evaluation test

    Time frame: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)

  2. Change in the clock-drawing test

    Time frame: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)

  3. Change in the Isaacs set test

    Time frame: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)

Secondary outcomes

  1. Time from reversal agent administration to extubation

    Time frame: After reversal agent administration

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Apr 17, 2015
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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