CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 140 enrolled
Drug / intervention
IV acetaminophen & IV propofol +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02546765
NCT02546765Phase 4Completed

Dexmedetomidine and IV Acetaminophen for the Prevention of Postoperative Delirium Following Cardiac Surgery in Adult Patients 60 Years of Age and Older

Beth Israel Deaconess Medical Center·interventional·Posted Sep 11, 2015·Updated Apr 9, 2020

In Brief

A Phase 4 clinical trial evaluating IV acetaminophen & IV propofol, IV acetaminophen & IV dexmedetomidine, and 2 other interventions for Delirium. Completed, enrolled 140 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDelirium
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 11, 2015
Enrollment StartOct 1, 2015
Primary CompletionMay 1, 2018
Study CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.8 years ago

Interventions

IV acetaminophen & IV propofoldrug

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

IV acetaminophen & IV dexmedetomidinedrug

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

IV propofol & placebodrug

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

IV dexmedetomidine & placebodrug

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