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.

NCT ID: NCT03107260

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-15
• Study Completion Date: 2018-07-13

Brief 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.

Conditions

Cerebral Saturation; Cognitive Impairment; Emergencies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Occurrence of postoperative cognitive dysfunction

Group Type: OTHER

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

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens Picardie

Amiens, Picardie, France

Site Status: RECRUITING

Countries

France

Central Contacts

Alexandre NTOUBA, Dr

Role: CONTACT

ntouba.alexandre@chu-amiens.fr

+33322668370

Facility Contacts

Alexandre NTOUBA, Dr

Role: primary

ntouba.alexandre@chu-amiens.fr

+33322668370

Other Identifiers

PI2015_843_0018

Identifier Type: -

Identifier Source: org_study_id