Decreasing the Incidence of Delirium After Cardiac Surgery

June 8, 2018 updated by: Jacques Neelankavil, University of California, Los Angeles
In critically ill surgical patients, delirium (confusion and disorientation) is extremely common and is associated with longer hospital length of stay, mortality, cost, and long term cognitive impairment. The goal of the study is to establish whether benzodiazepines (a sedative, anti-anxiety drug) should be used as part of standard of care or be eliminated by comparing the chances of delirium in cardiac surgery patients between two groups: a group that receives benzodiazepines during surgery versus a group that does not receive benzodiazepines during surgery. Benzodiazepines have historically been used in cardiac anesthesia to decrease the risk of anesthesia awareness. The current standard of care is to keep the patient on inhaled anesthesia throughout the surgery which eliminates the need for intraoperative use of benzodiazepines. Benzodiazepines are still used based on practitioner preference. Findings of this study will allow all anesthesiologists to make more informed decisions about what level of care our patients need.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

In critically ill surgical patients, delirium is extremely common and is associated with longer hospital length of stay, mortality, cost, and long term cognitive impairment. Benzodiazepine usage is common in anesthetic practice, and ICU literature demonstrates that limiting post-operative benzodiazepines decreases the incidence of delirium. However, the avoidance of preoperative and intraoperative benzodiazepines during cardiac surgery has not been studied in terms of its effect on delirium. The goal of the study is establish whether benzodiazepines should be used as part of standard of care or be eliminated by comparing the incidence of delirium in cardiac surgical patients when randomized to a group that receives benzodiazepines versus a group that does not receive benzodiazepines.

Potential subjects will be identified and recruited the day before surgery by primary investigators. Patients undergoing coronary artery bypass grafting or single valve procedures that consent to participate will be enrolled in the study. These patients may be consented during the pre-operative period. Patients will be informed that whether they enroll in the study or not, they will be receiving standard clinical care. Only subjects meeting all inclusion criteria and requirements for continuation in the study will be consented.

Patient will be randomized by age (age is a predictor of delirium) to 3 groups:

  • >80 years of age;
  • 70-80 years of age;
  • < 70 years of age.

Within these 3 groups, patients will be randomized to receive benzodiazepines during cardiac surgery or not. The anesthesiologist in the operating room will not be blinded to the group; however, the intensive care physician evaluating for delirium will be blinded to the treatment groups.

Benzodiazepine group:

  1. Premedication 0.02mg/kg-0.1mg/kg of midazolam;
  2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl;
  3. Postoperative 10-100mcg/kg/min of propofol

Non-benzodiazepine group:

  1. Premedication 0-50mg of propofol and/or 0-250mcg of fentanyl;
  2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl;
  3. Postoperative 10-100mcg/kg/min of propofol

Delirium can now be reliably diagnosed by non-psychiatrists in critically ill patients in less than 2 minutes through the use of validated monitoring instruments such as the Confusion Assessment Method for the ICU (CAM-ICU).

Study Type

Interventional

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 Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center, Department of Anesthesiology

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients' undergoing coronary artery bypass grafting or single valve procedures.

Exclusion Criteria:

  • Patients who have baseline cognitive dysfunction,
  • Patients with hearing problems,
  • Patients currently on benzodiazepines

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Benzodiazepine group
  1. Premedication 0.02mg/kg-0.1mg/kg of Benzodiazepine ;
  2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl;
  3. Postoperative 10-100mcg/kg/min of propofol
Drug: Benzodiazepine
Receive as premedication in the Benzodiazepine group.
Other Names:
  • Versed
  • Midazolam
Drug: Fentanyl
Receive as maintenance in the Benzodiazepine group. Can receive as premedication in the Non-Benzodiazepine group. Receive as maintenance in the Non-Benzodiazepine group.
Other Names:
  • Fentanil
Drug: Propofol
Receive postoperatively in the Benzodiazepine group. Can receive as premedication in the Non-Benzodiazepine group. Receive postoperatively in the Non-Can receive as premedication in the Non-Benzodiazepine group.
Other Names:
  • Diprivan
Active Comparator: Non-benzodiazepine group
  1. Premedication 0-50mg of propofol and/or 0-250mcg of fentanyl;
  2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl;
  3. Postoperative 10-100mcg/kg/min of propofol
Drug: Fentanyl
Receive as maintenance in the Benzodiazepine group. Can receive as premedication in the Non-Benzodiazepine group. Receive as maintenance in the Non-Benzodiazepine group.
Other Names:
  • Fentanil
Drug: Propofol
Receive postoperatively in the Benzodiazepine group. Can receive as premedication in the Non-Benzodiazepine group. Receive postoperatively in the Non-Can receive as premedication in the Non-Benzodiazepine group.
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delirium
Time Frame: less than 2 minutes
Delirium can now be reliably diagnosed by non-psychiatrists in critically ill patients in less than 2 minutes through the use of validated monitoring instruments such as the Confusion Assessment Method for the ICU (CAM-ICU)
less than 2 minutes

Collaborators and Investigators

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

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Jacques Neelankavil, M.D., University of California, Los Angeles

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 (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (Estimate)

April 22, 2014

Study Record Updates

Last Update Posted (Actual)

June 12, 2018

Last Update Submitted That Met QC Criteria

June 8, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Delirium 13-001412

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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