Delirium Reduction by Volatile Anesthesia in Cardiac Surgery (DELICATE)

January 11, 2024 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

353

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vladimir Lomivorotov, PHD
  • Phone Number: 383 347 60 54
  • Email: vvlom@mail.ru

Study Contact Backup

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • M.F. Vladimirsky Moscow Regional Research and Clinical Institute (MONIKI)
      • Novosibirsk, Russian Federation, 630055
        • Meshalkin Research Institute of Pathology of Circulation
      • Saint Petersburg, Russian Federation
        • Saint Petersburg State University Hospital
      • Tomsk, Russian Federation
        • Tomsk National Research Medical Center of the Russian Academy of Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
  • Isoflurane
  • Desflurane
Active Comparator: TIVA group
Drug: Propofol
Patients will receive propofol and no volatile agent. Propofol will be used for induction and maintenance of anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative delirium
Time Frame: 5 days after surgery
Postoperative delirium detection will be managed with Confusion Assessment Method for the ICU (CAM-ICU)
5 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early postoperative cognitive dysfunction
Time Frame: 7 days after surgery
We will use Montreal Cognitive Assessment (MoCA) to detect cognitive dysfunction
7 days after surgery
Delirium duration
Time Frame: 10 days after surgery
number of days
10 days after surgery
Duration of ICU stay
Time Frame: 30 days
number of days
30 days
Duration of hospital stay
Time Frame: 60 days
number of days
60 days
30-day all-cause mortality
Time Frame: 30 days
yes/no
30 days
One-year all-cause mortality
Time Frame: 1 year
yes/no
1 year
Myocardial infarction (MI)
Time Frame: 30 days
yes/no
30 days
Stroke
Time Frame: 30 days
Stroke will be diagnosed by neurologist (yes/no)
30 days
Seizures
Time Frame: 30 days
Presence of Seizures (yes/no)
30 days
Incidence of acute kidney injury (AKI)
Time Frame: 30 days
According to KDIGO criteria
30 days
Renal replacement therapy
Time Frame: 30 days
We will collect data about need of renal replacement therapy (yes/no)
30 days
Infectious complications
Time Frame: 30 days
We will collect data about infectious complications: wound infection, mediastinitis, pneumonia, positive blood culture
30 days
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.
5 days after surgery
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.
5 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2019

Primary Completion (Actual)

January 11, 2024

Study Completion (Actual)

January 11, 2024

Study Registration Dates

First Submitted

October 3, 2018

First Submitted That Met QC Criteria

November 1, 2018

First Posted (Actual)

November 2, 2018

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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