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Decreasing the Incidence of Delirium After Cardiac Surgery

Primary Purpose

C.Surgical Procedure; Cardiac, Delirium

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Benzodiazepine
Fentanyl
Propofol
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for C.Surgical Procedure; Cardiac focused on measuring cardiac surgery, benzodiazepines, delirium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ronald Reagan UCLA Medical Center, Department of Anesthesiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Benzodiazepine group

Non-benzodiazepine group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Delirium
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)

Secondary Outcome Measures

Full Information

First Posted
April 17, 2014
Last Updated
June 8, 2018
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02119806
Brief Title
Decreasing the Incidence of Delirium After Cardiac Surgery
Official Title
Decreasing the Incidence of Delirium After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study was never initiated.
Study Start Date
August 2017 (Anticipated)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: Premedication 0.02mg/kg-0.1mg/kg of midazolam; Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl; Postoperative 10-100mcg/kg/min of propofol Non-benzodiazepine group: Premedication 0-50mg of propofol and/or 0-250mcg of fentanyl; Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl; 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C.Surgical Procedure; Cardiac, Delirium
Keywords
cardiac surgery, benzodiazepines, delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Benzodiazepine group
Arm Type
Active Comparator
Arm Description
Premedication 0.02mg/kg-0.1mg/kg of Benzodiazepine ; Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl; Postoperative 10-100mcg/kg/min of propofol
Arm Title
Non-benzodiazepine group
Arm Type
Active Comparator
Arm Description
Premedication 0-50mg of propofol and/or 0-250mcg of fentanyl; Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl; Postoperative 10-100mcg/kg/min of propofol
Intervention Type
Drug
Intervention Name(s)
Benzodiazepine
Other Intervention Name(s)
Midazolam, Versed
Intervention Description
Receive as premedication in the Benzodiazepine group.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Fentanil
Intervention Description
Receive as maintenance in the Benzodiazepine group. Can receive as premedication in the Non-Benzodiazepine group. Receive as maintenance in the Non-Benzodiazepine group.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Delirium
Description
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)
Time Frame
less than 2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Neelankavil, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center, Department of Anesthesiology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11730446
Citation
Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.
Results Reference
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PubMed Identifier
11797025
Citation
Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.
Results Reference
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PubMed Identifier
15082703
Citation
Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
Results Reference
background
PubMed Identifier
19745202
Citation
Pisani MA, Kong SY, Kasl SV, Murphy TE, Araujo KL, Van Ness PH. Days of delirium are associated with 1-year mortality in an older intensive care unit population. Am J Respir Crit Care Med. 2009 Dec 1;180(11):1092-7. doi: 10.1164/rccm.200904-0537OC. Epub 2009 Sep 10.
Results Reference
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PubMed Identifier
20473145
Citation
Girard TD, Jackson JC, Pandharipande PP, Pun BT, Thompson JL, Shintani AK, Gordon SM, Canonico AE, Dittus RS, Bernard GR, Ely EW. Delirium as a predictor of long-term cognitive impairment in survivors of critical illness. Crit Care Med. 2010 Jul;38(7):1513-20. doi: 10.1097/CCM.0b013e3181e47be1.
Results Reference
background
PubMed Identifier
15071384
Citation
Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.
Results Reference
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Decreasing the Incidence of Delirium After Cardiac Surgery

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