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.

Cognitive Impairment Clinical Trial

— NIRS-1  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03107260
• Other study ID #: PI2015_843_0018
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2017
• Last updated: April 5, 2017
• Start date: January 15, 2016
• Est. completion date: July 13, 2018

Study information

• Verified date: April 2017
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Alexandre NTOUBA, Dr
• Phone: +33322668370
• Email: ntouba.alexandre[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 13, 2018
• Est. primary completion date: July 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cerebral Saturation
• Cognition Disorders
• Cognitive Impairment
• Emergencies

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of POCD		72 hours