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. 2018 Aug 21;2018(8):CD012317. doi: 10.1002/14651858.CD012317.pub2

NCT02133638.

Trial name or title Sevoflurane decreases the risk of postoperative delirium after cerebral hypoxemia during surgery
Methods RCT, parallel design
Participants Target number of randomized participants: 130
Inclusion criteria
  1. ASA III to IV, history of arterial vascular disease (arterial hypertension, myocardial ischaemia and/or cerebral vascular disease), undergoing elective non‐cardiac surgery (hemicolectomy, hernioplasty, laparoscopic cholecystectomy and laparoscopic hysterectomy), 65 to 80 years of age


Exclusion criteria
  1. Dementia

  2. Stroke or myocardial infarction ≤ 6 months before surgery

  3. Oncological disease of T2‐4N3M1 stage


Type of surgery: elective non‐cardiac surgery (hemicolectomy, hernioplasty, laparoscopic cholecystectomy and laparoscopic hysterectomy)
Country: Russia
Setting: hospital
Interventions TIVA group
Induction details: propofol 2 mg/kg and fentanyl 4 µg/kg
Maintenance details: infusion of propofol 8 mg/kg/hour and boluses of fentanyl 3 µg/kg
Inhalational maintenance group
Induction details: fentanyl 2 µg/kg and a bolus inhalation of 8% sevoflurane in an 8 L/min fresh gas flow
Maintenance details: 1 MAC sevoflurane at a low fresh gas flow of 0.6 to 0.8 L/min in a 60% air‐oxygen mixture supplemented with boluses of fentanyl
Outcomes
  1. Regional cerebral oxygenation

  2. Peripheral tissue oxygen saturation

  3. Non‐invasive blood pressure

  4. Postoperative delirium (using CAM 24 and 48 hours postoperatively)

  5. Plasma concentration of S100b protein

Starting date May 2014
Contact information Yuri V Iljin, Negovsky Reanimatology Research Institute, Moscow, Russia
Notes