Sevoflurane Decreases the Risk of Postoperative Delirium After Cerebral Hypoxemia During Surgery

Negovsky Reanimatology Research Institute

Status and phase: Unknown; Phase 4

Conditions: Cerebral Hypoxia; Postoperative Delirium

Treatments: Drug: Sevoflurane; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02133638

Sev003

s100b (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Sevoflurane

Active Comparator group

Description:

Sevoflurane Based Volatile Induction and Maintenance of Anaesthesia

Treatment:

Drug: Sevoflurane

Propofol

Active Comparator group

Description:

Propofol Based Total Intravenous Anesthesia

Treatment:

Drug: Propofol