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

Phase 4

• Conditions: Cerebral Hypoxia; Postoperative Delirium
• Interventions: Drug: Propofol; Drug: Sevoflurane

• Registration Number: NCT02133638
• Lead Sponsor: Negovsky Reanimatology Research Institute

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.

Study Timeline

• Status Verified: 2014-05
• Study Start: 2014-05
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-06
• Last Update Submitted: 2014-05-06
• Study First Posted: 2014-05-08
• Last Update Posted: 2014-05-08
• Primary Completion: 2015-05
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Propofol Based Total Intravenous Anesthesia
Sevoflurane	Sevoflurane	Sevoflurane Based Volatile Induction and Maintenance of Anaesthesia

Primary Outcome Measures

Name	Time	Method
Regional Cerebral Oxygenation (rSO2)	Continued the entire surgery
Peripheral tissue oxygen saturation (SpO2)	Continued the entire surgery
Non-invasive blood pressure (NIBP)	Continued the entire surgery

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of S100b protein	Baseline, 24h and 48h after surgery	S100b protein is the neuronal injury marker
Number of Incidences of postoperative delirium (POD)	Baseline, 24h and 48h after surgery	Applying the Confusion Assessment Method for the ICU (CAM-ICU)

Trial Locations

Locations (1)

Medical center of the Main Administration for Service to the Diplomatic Corps; 🇷🇺 Moscow, Russian Federation