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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02133638
Enrollment
130
Registered
2014-05-08
Start date
2014-05-31
Completion date
2015-06-30
Last updated
2014-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Hypoxia, Postoperative Delirium

Keywords

Delirium, Hypoxic Brain Damage, Propofol, S100b protein, Sevoflurane

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.

Interventions

DRUGSevoflurane

Induction of anesthesia: fentanyl 2 µg kg-1 and a bolus inhalation of 8% sevoflurane in an 8 L.min-1 fresh gas flow. Anesthesia maintenance: 1 minimal alveolar concentration (MAC) sevoflurane at a low fresh gas flow of 0.6-0.8 L min-1 in a 60% air-oxygen mixture supplemented with boluses of fentanyl.

DRUGPropofol

Induction of anesthesia: propofol 2 mg kg-1 and fentanyl 4 µg kg-1. Maintenance of anesthesia: infusion of propofol 8 mg kg-1 h-1 and boluses of fentanyl 3 µg kg-1.

Sponsors

Negovsky Reanimatology Research Institute
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Number of Incidences of postoperative delirium (POD)Baseline, 24h and 48h after surgeryApplying the Confusion Assessment Method for the ICU (CAM-ICU)
Plasma concentration of S100b proteinBaseline, 24h and 48h after surgeryS100b protein is the neuronal injury marker

Countries

Russia

Contacts

Primary ContactValery V. Likhvantsev, MD, Prof.
lik0704@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026