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Delirium Reduction by Volatile Anesthesia in Cardiac Surgery

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03729011
Acronym
DELICATE
Enrollment
405
Registered
2018-11-02
Start date
2019-01-09
Completion date
2024-01-11
Last updated
2025-05-15

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

Conditions

Delirium

Keywords

delirium, Cardiac surgery, Cardiopulmonary bypass, Cognitive dysfunction

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.

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.

Interventions

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.

DRUGPropofol

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

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

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.

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative delirium5 days after surgeryPostoperative delirium detection will be managed with Confusion Assessment Method for the ICU (CAM-ICU)

Secondary

MeasureTime frameDescription
One-year all-cause mortality1 yearyes/no
Myocardial infarction (MI)30 daysyes/no
Early postoperative cognitive dysfunction7 days after surgeryWe will use Montreal Cognitive Assessment (MoCA) to detect cognitive dysfunction
Delirium duration10 days after surgerynumber of days
Duration of ICU stay30 daysnumber of days
Duration of hospital stay60 daysnumber of days
Stroke30 daysStroke will be diagnosed by neurologist (yes/no)
Seizures30 daysPresence of Seizures (yes/no)
Incidence of acute kidney injury (AKI)30 daysAccording to KDIGO criteria
Renal replacement therapy30 daysWe will collect data about need of renal replacement therapy (yes/no)
Infectious complications30 daysWe will collect data about infectious complications: wound infection, mediastinitis, pneumonia, positive blood culture
Pain assessment with Behavioral Pain Scale (BPS)5 days after surgeryThe 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.
Pain assessment with Numerical Rating Scale (NRS)5 days after surgeryA 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.
30-day all-cause mortality30 daysyes/no

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026