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OpenTrials
Completed

NCT Number: NCT03107260

The Association Between Variation in Oxygen Saturation (ScO2) and Incidence of Postoperative Cognitive Dysfunction (POCD) in a Population of Elderly Patients Admitted for Emergency Surgery.

There is no study of the association between ScO2 and POCD in non-cardiac, thoracic or vascular surgery. The few studies found in cardiac, thoracic and vascular surgery show an incidence up to 50% with a variation of the ScO2 threshold which varies between 15 and 25% according to the studies.

Age is the main risk of OCDD. The management of this pathology should be early to avoid loss of autonomy of the patient. Finding a relationship, if it exists, would therefore significantly improve the mortality and morbidity of the said patient.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 65 years
  • Non-cardiac, thoracic and vascular emergency surgery
  • Surgery under general anesthesia
  • ASA I, II or III
  • Simple information without consent
  • Patient affiliated to social security

Exclusion criteria

  • Inability to understand
  • Patient under tutelage, or curatorship or deprived of public right
  • ASA IV
  • History of severe dementia MMSE <20
  • Personal or familial history of malignant hyperthermia
  • History of allergy or hypersensitivity to anesthetic products used
  • Contra-indication to Cisatracurium®: myasthenia gravis
  • Contra-indication to Sevoflurane®
  • Contra-indication to local anesthetics
  • Indication of use of a Ketamine®-type hypnotic (modification of the BIS)
  • Indication of use of nitrous oxide
  • History of cranial trauma
  • Neuromuscular pathology
  • Spinal anesthesia
  • Cardiac, thoracic or vascular surgery
  • Surgery not performed in emergency
  • Neurochirugia in the context of cranial trauma
  • Any surgery that does not allow the use of the NIRS (impossibility of positioning of the electrodes by the location of the surgical field).

Treatment and study plan

To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patients

Other

Evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in non-cardiac, thoracic and vascular emergency surgery in patients 65 years of age and older. The occurrence of POCD will be defined by the MMSE decrease of at least 4 points at 24, 48 or 72 hours

Primary outcomes

  1. Occurrence of POCD

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: NIRS-1

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2017
Registry last updated
Jun 11, 2026

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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