Clinical trial NCT02133638: Sevoflurane Decreases the Risk of Postoperative Delirium After Cerebral Hypoxemia During Surgery
Official title: Sevoflurane-based Volatile Induction and Maintenance of Anaesthesia (VIMA) Strategy Decreases the Risk of Postoperative Delirium in Elderly Patients With Registered Cerebral Hypoxemia Episodes During General Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cerebral Hypoxia
Postoperative Delirium
Keywords: Delirium
Hypoxic Brain Damage
Propofol
S100b protein
Sevoflurane
Lead sponsor: Negovsky Reanimatology Research Institute
Sponsor class: OTHER_GOV
First posted: 2014-05-08
Enrollment: 130
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to distinguish possible differences in frequency of delirium after Volatile Induction and Maintenance of Anesthesia and Total Intravenous Anesthesia in case of undeliberate cerebral desaturation during non-cardiac surgery.

Detailed description: The aim of the present study is to investigate whether in non-cardiac surgery the frequency of POD after intraoperative undeliberate cerebral saturation could be modulated by the choice of the anesthetic strategy (Volatile Induction and Maintenance of Anesthesia \[VIMA\] and Total Intravenous Anesthesia \[TIVA\]). Based on our previous data we hypothesized that incidence of POD would be lower with VIMA compared to TIVA.

Eligibility criteria: Inclusion Criteria:

* class III-IV by physical status classification system of American Society of Anesthesiologist (ASA)
* history of arterial vascular disease (arterial hypertension, myocardial ischemia and/or cerebral vascular disease)
* undergoing elective non-cardiac surgery (hemicolectomy, hernioplasty, laparoscopic cholecystectomy and laparoscopic hysterectomy)

Exclusion Criteria:

* dementia
* stroke or myocardial infarction ≤ 6 months before surgery
* oncological disease of T2-4N3M1 stage

Primary outcomes:
measure: Regional Cerebral Oxygenation (rSO2)
timeFrame: Continued the entire surgery
measure: Peripheral tissue oxygen saturation (SpO2)
timeFrame: Continued the entire surgery
measure: Non-invasive blood pressure (NIBP)
timeFrame: Continued the entire surgery
Secondary outcomes:
measure: Number of Incidences of postoperative delirium (POD)
timeFrame: Baseline, 24h and 48h after surgery
measure: Plasma concentration of S100b protein
timeFrame: Baseline, 24h and 48h after surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Medical center of the Main Administration for Service to the Diplomatic Corps
Study officials:
affiliation: Negovsky Reanimatology Research Institute, Moscow, Russia
name: Valery V. Likhvantsev, MD, Prof.
role: STUDY_CHAIR
affiliation: Negovsky Reanimatology Research Institute, Moscow, Russia
name: Oleg A. Grebenchikov, MD, PhD
role: STUDY_DIRECTOR
affiliation: Negovsky Reanimatology Research Institute, Moscow, Russia
name: Yuri V. Iljin
role: PRINCIPAL_INVESTIGATOR
affiliation: Negovsky Reanimatology Research Institute, Moscow, Russia
name: Alexander V. Mironenko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Negovsky Reanimatology Research Institute, Moscow, Russia
name: Yuri V. Skripkin
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Maria Vittoria, Turin, Italy
name: Dmitriy B. Selivanov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: