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Delirium Reduction by Volatile Anesthesia in Cardiac Surgery (DELICATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03729011
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

Brief Summary:
Parallel group, prospective, randomized, controlled, single-blinded trial. The aim of our study is to test the hypothesis that volatile anesthesia would reduce the incidence of early postoperative delirium in patients undergoing cardiac surgery with CPB as compared to TIVA.

Condition or disease Intervention/treatment Phase
Delirium Drug: Volatile agent Drug: Propofol Phase 4

Detailed Description:

Delirium is a common neurologic complication after cardiac surgery. Up to 52% of postoperative cardiac surgery patients have delirium. The occurrence of postoperative delirium is associated with worse outcomes, including prolonged length of stay in the ICU and hospital, increased morbidity and mortality, compromised long-term cognitive function and physical ability, and elevated medical care costs. Morbidity of postoperative cognitive dysfunction and delirium mostly common in patients with age more than 60 years.

Several factors including cerebral anoxia, embolism, excessive excitatory neurotransmitter release, systemic inflammatory response, electrolyte and metabolic disorders and hemodynamic changes have been demonstrated to contribute to postoperative neurological dysfunction and delirium.

Previous studies have shown that inhalation anaesthesia and total intravenous anaesthesia (TIVA) may produce different degrees of cerebral protection in these patients. Effects of this two types of anaesthesia in cardiac surgery with CPB remain controversial and much debated.

Inhalation agents depress glucose metabolism, decrease cerebral metabolic rate and oxygen consumption. They also partially uncouple the reactivity of cerebral blood flow to CO2. The changes in cerebral blood flow (CBF) depend on the changes in cerebral metabolism and on direct vasodilatory effects. Cerebral autoregulation is dose-dependently altered. Volatile anaesthetics have been shown to initiate early ischemic preconditioning in neurons, but models of focal brain ischemia suggest it can take 24 h for preconditioning to develop fully.

Propofol is a well-known potentiator of GABAA receptors, it reduces cerebrovascular resistance, CBF and cerebral oxygen delivery during cardiopulmonary bypass. A neuroprotective effect of propofol has been shown to be present in many in vitro and in vivo established experimental models of mild/moderate acute cerebral ischemia.

In recent meta-analysis of 13 randomized controlled studies Chen et al compared the neuroprotective effects of inhalational anesthesia and those of total intravenous anesthesia (TIVA) in cardiac surgery with cardiopulmonary bypass. They have shown that anesthesia with volatile agents appeared to provide better cerebral protection than TIVA. As this meta-analysis had several limitations (small sample size of included studies, high heterogenity, etc.), further studies with larger clinically relevant sample-sizes are needed to demonstrate which anesthetics are more beneficial in terms of brain protection in cardiac surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 672 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomly allocated to receive either inhalation anaesthesia or TIVA. Permuted-block randomization will be used to allocate subjects to one of the study groups. Sequentially numbered sealed opaque envelopes will contain the treatment code, to be opened in the morning of surgery. Patients will be unaware of group assignment. All the statistical analyses will be performed by the biostatistician not involved in treatment allocation.
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Delirium Reduction by Volatile Anesthesia in Cardiac Surgery: Prospective, Randomized, Single-blinded Study
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : December 29, 2021
Estimated Study Completion Date : January 29, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Active Comparator: Volatile anesthesia group Drug: Volatile agent
Patients will receive volatile agent to provide general anaesthesia, including CPB period. Volatile agents will be administered from anesthesia induction to the end of surgery. Concentration (MAC) of volatile agent will be selected by anaesthesiologist according to clinical situation and patient features.
Other Names:
  • Sevoflurane
  • Desflurane
  • Isoflurane

Active Comparator: TIVA group Drug: Propofol
Patients will receive propofol and no volatile agent. Propofol will be used for induction and maintenance of anesthesia.




Primary Outcome Measures :
  1. Postoperative delirium [ Time Frame: 5 days after surgery ]
    Postoperative delirium detection will be managed with Confusion Assessment Method for the ICU (CAM-ICU)


Secondary Outcome Measures :
  1. Early postoperative cognitive dysfunction [ Time Frame: 7 days after surgery ]
    We will use Montreal Cognitive Assessment (MoCA) to detect cognitive dysfunction

  2. Delirium duration [ Time Frame: 10 days after surgery ]
    number of days

  3. Duration of ICU stay [ Time Frame: 30 days ]
    number of days

  4. Duration of hospital stay [ Time Frame: 60 days ]
    number of days

  5. 30-day all-cause mortality [ Time Frame: 30 days ]
    yes/no

  6. One-year all-cause mortality [ Time Frame: 1 year ]
    yes/no

  7. Myocardial infarction (MI) [ Time Frame: 30 days ]
    yes/no

  8. Stroke [ Time Frame: 30 days ]
    Stroke will be diagnosed by neurologist (yes/no)

  9. Seizures [ Time Frame: 30 days ]
    Presence of Seizures (yes/no)

  10. Incidence of acute kidney injury (AKI) [ Time Frame: 30 days ]
    According to KDIGO criteria

  11. Renal replacement therapy [ Time Frame: 30 days ]
    We will collect data about need of renal replacement therapy (yes/no)

  12. Infectious complications [ Time Frame: 30 days ]
    We will collect data about infectious complications: wound infection, mediastinitis, pneumonia, positive blood culture

  13. Pain assessment with Behavioral Pain Scale (BPS) [ Time Frame: 5 days after surgery ]
    The BPS is an observational pain scale. It has been validated for use in deeply sedated, mechanically ventilated patients. The BPS contains 3 subscales: facial expression, upper limb movements, and compliance with mechanical ventilation. Each subscale is scored from 1 (no response) to 4 (full response). Therefore, BPS scores range from 3 (no pain) to 12 (maximal pain). A BPS score of 6 or higher is considered to reflect unacceptable pain.

  14. Pain assessment with Numerical Rating Scale (NRS) [ Time Frame: 5 days after surgery ]
    A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) or from 0 to 100 (101 point scale) with the understanding that 0 is equal to no pain and 10 or 100 is equal to worst possible pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females > 65 years
  • Written informed consent
  • Cardiac surgery with CPB

Exclusion Criteria:

  • Emergency surgery
  • Surgery on aorta
  • Known allergy to components of anaesthesia
  • Pregnancy
  • Hemodynamically significant stenosis of carotid arteries
  • Parkinson's disease
  • Liver cirrhosis (Child B or C)
  • Current enrollment into another RCT (in the last 30 days)
  • Previous enrollment and randomization into the DELICATE trial
  • Poor language comprehension
  • Preoperative Medications: Anticholinergics (dimedrol, atropine, dramina), antidepressants, antiepileptics, antiparkinson drugs, chemotherapeutic agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729011


Contacts
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Contact: Vladimir Lomivorotov, PHD 347 60 54 ext 383 vvlom@mail.ru
Contact: Gleb Moroz, PHD 347 60 54 ext 383 Glebmorozz@gmail.com

Locations
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Russian Federation
M.F. Vladimirsky Moscow Regional Research and Clinical Institute (MONIKI) Recruiting
Moscow, Russian Federation
Contact: Valery Lichvancev       lik0704@gmail.com   
Contact: Galina Titova       galinatitova@mail.ru   
Meshalkin Research Institute of Pathology of Circulation Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Vladimir Lomivorotov    3833476058    v.lomivorotov@gmail.com   
Saint Petersburg State University Hospital Recruiting
Saint Petersburg, Russian Federation
Contact: Sergey Efremov, PHD       efremovsergm@gmail.com   
Tomsk National Research Medical Center of the Russian Academy of Sciences Recruiting
Tomsk, Russian Federation
Contact: Nikolay Kamenshikov       nikolajkamenof@mail.ru   
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Publications:

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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT03729011    
Other Study ID Numbers: 18
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
delirium
Cardiac surgery
Cardiopulmonary bypass
Cognitive dysfunction
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Propofol
Sevoflurane
Desflurane
Isoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation