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Dexmedetomidine and IV Acetaminophen for the Prevention of Postoperative Delirium Following Cardiac Surgery

NCT02546765 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2020-04-09

Study results available
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Summary

Investigators will assess the incidence and duration of postoperative delirium in patients ≥60 years old undergoing coronary artery bypass grafting (CABG), with/without valve surgery (aortic and/or mitral) based on different regimens for postoperative sedation and analgesia. Patients will receive either intravenous (IV) dexmedetomidine and IV acetaminophen or standard postoperative management using IV propofol with morphine or hydromorphone. The Confusion Assessment Method (CAM) will be used to assess delirium in these patients. Investigators also seek to compare postoperative (48 hours) analgesic requirements in patients with or without IV acetaminophen. Investigators will finally assess postoperative cognition in post-surgical patients up to one year post-discharge using a cognitive assessment scale.

Conditions

  • Delirium

Interventions

DRUG

IV acetaminophen & IV propofol

use of IV tylenol and IV propofol for pain and sedation (respectively)

DRUG

IV acetaminophen & IV dexmedetomidine

use of IV tylenol and IV dexmedetomidine for pain and sedation (respectively)

DRUG

IV propofol & placebo

use of IV propofol for sedation and morphine, the drug of choice for cardiac pain

DRUG

IV dexmedetomidine & placebo

use of IV dexmedetomidine for sedation and morphine, the drug of choice for cardiac pain

Sponsors & Collaborators

Principal Investigators

  • Balachundhar Subramaniam, MD, MPH · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-05-31
Completion
2019-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT02546765 on ClinicalTrials.gov