Cerebral HypoxiaPhase 4NCT02133638
Sevoflurane Decreases the Risk of Postoperative Delirium After Cerebral Hypoxemia During Surgery
A Phase 4 study testing Sevoflurane and Propofol in people with Cerebral Hypoxia and Postoperative Delirium, run by Negovsky Reanimatology Research Institute at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Cerebral Hypoxia, Postoperative Delirium
- What is being tested?
- Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteRussia
- Study dates
- May 2014to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- dementia
- stroke or myocardial infarction ≤ 6 months before surgery
- oncological disease of T2-4N3M1 stage
Trial locations and contacts
1 site in 1 country.
Valery V. Likhvantsev, MD, Prof. contact
Russia1 site, 1 recruiting
- Recruiting
Medical center of the Main Administration for Service to the Diplomatic Corps
Moscow
Yuri V. Skripkin, skripkin62@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Cerebral Hypoxia, Postoperative Delirium
- Being tested
- Sevoflurane, Propofol
- Keywords
- Delirium, Hypoxic Brain Damage, Propofol, S100b protein, Sevoflurane
- Medical subject headings
- Hypoxia, Brain, Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevorane, Ultane, Fluoromethyl hexafluoroisopropyl ether
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.
PropofolDrug
Also called Diprivan, Lipuro, Propolipid, Propoven
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.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | Sevoflurane Based Volatile Induction and Maintenance of Anaesthesia Receives: Drug: Sevoflurane |
| Propofol | Active comparator | Propofol Based Total Intravenous Anesthesia Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Cerebral Oxygenation (rSO2)
Measured: Continued the entire surgery
Peripheral tissue oxygen saturation (SpO2)
Measured: Continued the entire surgery
Non-invasive blood pressure (NIBP)
Measured: Continued the entire surgery
Secondary outcomes (2)
Number of Incidences of postoperative delirium (POD)
Applying the Confusion Assessment Method for the ICU (CAM-ICU)
Measured: Baseline, 24h and 48h after surgery
Plasma concentration of S100b protein
S100b protein is the neuronal injury marker
Measured: Baseline, 24h and 48h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Negovsky Reanimatology Research Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Valery V. Likhvantsev, MD, Prof., Study chair, Negovsky Reanimatology Research Institute, Moscow, RussiaOleg A. Grebenchikov, MD, PhD, Study director, Negovsky Reanimatology Research Institute, Moscow, RussiaYuri V. Iljin, Principal investigator, Negovsky Reanimatology Research Institute, Moscow, RussiaAlexander V. Mironenko, MD, PhD, Principal investigator, Negovsky Reanimatology Research Institute, Moscow, RussiaYuri V. Skripkin, Principal investigator, Negovsky Reanimatology Research Institute, Moscow, RussiaDmitriy B. Selivanov, MD, PhD, Principal investigator, Hospital Maria Vittoria, Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133638
- Sponsor's protocol ID
- Sev003
- Other IDs
- s100b
- Status last verified
- May 2014
- First submitted
- 6 May 2014
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02133638
- Acronym / sponsor ID
- Sev003
- Conditions
- Cerebral Hypoxia, Postoperative Delirium
- Keywords
- Delirium, Hypoxic Brain Damage, Propofol, S100b protein, Sevoflurane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Negovsky Reanimatology Research InstituteOther government
- Study start
- May 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 8 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Drug: SevofluraneSevoflurane Based Volatile Induction and Maintenance of Anaesthesia |
| Propofol | Active comparator | Drug: PropofolPropofol Based Total Intravenous Anesthesia |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- dementia
- stroke or myocardial infarction ≤ 6 months before surgery
- oncological disease of T2-4N3M1 stage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneAlso: Sevorane, Ultane, Fluoromethyl hexafluoroisopropyl etherInduction 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. | Drug | Sevoflurane |
| PropofolAlso: Diprivan, Lipuro, Propolipid, PropovenInduction 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. | Drug | Propofol |
Primary outcome
Regional Cerebral Oxygenation (rSO2)
Time frame: Continued the entire surgery
Peripheral tissue oxygen saturation (SpO2)
Time frame: Continued the entire surgery
Non-invasive blood pressure (NIBP)
Time frame: Continued the entire surgery
2 secondary outcomes
Number of Incidences of postoperative delirium (POD)
Time frame: Baseline, 24h and 48h after surgery
Plasma concentration of S100b protein
Time frame: Baseline, 24h and 48h after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valery V. Likhvantsev, MD, Prof. contact
Valery V. Likhvantsev, MD, Prof. study chair
Negovsky Reanimatology Research Institute, Moscow, Russia
Oleg A. Grebenchikov, MD, PhD study director
Negovsky Reanimatology Research Institute, Moscow, Russia
Yuri V. Iljin principal investigator
Negovsky Reanimatology Research Institute, Moscow, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane and Propofol in people with Cerebral Hypoxia and Postoperative Delirium, run by Negovsky Reanimatology Research Institute at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valery V. Likhvantsev, MD, Prof. (lik0704@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Cerebral Oxygenation (rSO2) (time frame: Continued the entire surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2014.