Delirium Reduction by Volatile Anesthesia in Cardiac Surgery
- Registration Number
- NCT03729011
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 353
- Males and females > 65 years
- Written informed consent
- Cardiac surgery with CPB
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Volatile anesthesia group Volatile agent - TIVA group Propofol -
- Primary Outcome Measures
Name Time Method Postoperative delirium 5 days after surgery Postoperative delirium detection will be managed with Confusion Assessment Method for the ICU (CAM-ICU)
- Secondary Outcome Measures
Name Time Method Myocardial infarction (MI) 30 days yes/no
Duration of ICU stay 30 days number of days
One-year all-cause mortality 1 year yes/no
Early postoperative cognitive dysfunction 7 days after surgery We will use Montreal Cognitive Assessment (MoCA) to detect cognitive dysfunction
Delirium duration 10 days after surgery number of days
Duration of hospital stay 60 days number of days
30-day all-cause mortality 30 days yes/no
Stroke 30 days Stroke will be diagnosed by neurologist (yes/no)
Seizures 30 days Presence of Seizures (yes/no)
Incidence of acute kidney injury (AKI) 30 days According to KDIGO criteria
Renal replacement therapy 30 days We will collect data about need of renal replacement therapy (yes/no)
Infectious complications 30 days We will collect data about infectious complications: wound infection, mediastinitis, pneumonia, positive blood culture
Pain assessment with Behavioral Pain Scale (BPS) 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.
Pain assessment with Numerical Rating Scale (NRS) 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.
Trial Locations
- Locations (4)
Tomsk National Research Medical Center of the Russian Academy of Sciences
🇷🇺Tomsk, Russian Federation
Saint Petersburg State University Hospital
🇷🇺Saint Petersburg, Russian Federation
Meshalkin Research Institute of Pathology of Circulation
🇷🇺Novosibirsk, Russian Federation
M.F. Vladimirsky Moscow Regional Research and Clinical Institute (MONIKI)
🇷🇺Moscow, Russian Federation