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Decreasing the Incidence of Delirium After Cardiac Surgery

NCT02119806 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2018-06-12

No results posted yet for this study

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.

Conditions

  • C.Surgical Procedure; Cardiac
  • Delirium

Interventions

DRUG

Benzodiazepine

Receive as premedication in the Benzodiazepine group.

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Jacques Neelankavil, M.D. · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2017-08-31
Completion
2017-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02119806 on ClinicalTrials.gov