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NCT Number: NCT03729011

Delirium Reduction by Volatile Anesthesia in Cardiac Surgery

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

M.F. Vladimirsky Moscow Regional Research and Clinical Institute (MONIKI), Moscow, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volatile agent

Drug

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

Propofol

Drug

Patients will receive propofol and no volatile agent. Propofol will be used for induction and maintenance of anesthesia.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

Delirium Reduction by Volatile Anesthesia in Cardiac Surgery: Prospective, Randomized, Single-blinded Study

Acronym: DELICATE

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2018
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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