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. (NIRS-1)

Centre Hospitalier Universitaire, Amiens

Status: Unknown

Conditions: Emergencies; Cognitive Impairment; Cerebral Saturation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03107260

PI2015_843_0018

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Occurrence of postoperative cognitive dysfunction

Other group

Treatment:

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