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

Postoperative Delirium Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02133638
• Other study ID #: Sev003
• Secondary ID: s100b
• Status: Recruiting
• Phase: Phase 4
• First received: May 6, 2014
• Last updated: May 6, 2014
• Start date: May 2014
• Est. completion date: June 2015

Study information

• Verified date: May 2014
• Source: Negovsky Reanimatology Research Institute
• Contact: Valery V. Likhvantsev, MD, Prof.
• Email: lik0704[@]gmail.com
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Hypoxia
• Delirium
• Hypoxia, Brain
• Postoperative Delirium

Intervention

Drug:
• Sevoflurane
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.
• Propofol
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.

Locations

Country	Name	City	State
Russian Federation	Medical center of the Main Administration for Service to the Diplomatic Corps	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Negovsky Reanimatology Research Institute

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional Cerebral Oxygenation (rSO2)		Continued the entire surgery	Yes
Primary	Peripheral tissue oxygen saturation (SpO2)		Continued the entire surgery	Yes
Primary	Non-invasive blood pressure (NIBP)		Continued the entire surgery	Yes
Secondary	Number of Incidences of postoperative delirium (POD)	Applying the Confusion Assessment Method for the ICU (CAM-ICU)	Baseline, 24h and 48h after surgery	Yes
Secondary	Plasma concentration of S100b protein	S100b protein is the neuronal injury marker	Baseline, 24h and 48h after surgery	Yes