- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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. (NIRS-1)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexandre NTOUBA, Dr
- Phone Number: +33322668370
- Email: ntouba.alexandre@chu-amiens.fr
Study Locations
-
-
Picardie
-
Amiens, Picardie, France, 80054
- Recruiting
- CHU Amiens Picardie
-
Contact:
- Alexandre NTOUBA, Dr
- Phone Number: +33322668370
- Email: ntouba.alexandre@chu-amiens.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Occurrence of postoperative cognitive dysfunction
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of POCD
Time Frame: 72 hours
|
72 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2015_843_0018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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