CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
Sugammadex +1 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/NCT03196167
NCT03196167Phase 4Completed

Efficacy and Safety of Sugammadex (2mg/kg) to Shorten Time-to-extubation Among Postoperative ICU Patients Following AVR, CABG Surgery, or AVR/CABG Surgery- a Prospective Randomized Placebo-controlled Trial.

Yale University·interventional·Posted Jun 22, 2017·Updated Jan 14, 2022

In Brief

A Phase 4 clinical trial evaluating Sugammadex and Placebo for Coronary Artery Bypass Graft and/or Aortic Valve Replacement Surgery. Completed, enrolled 90 participants across 1 site.

Detailed Summary

The purpose of this study is to demonstrate faster time to extubation after arrival in the cardiothoracic intensive care unit (ICU) in patients undergoing isolated coronary artery bypass grafting (CABG), AVR and AVR/CABG combination who receive Sugammadex as compared to placebo.

Study Details

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

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJun 22, 2017
Enrollment StartMay 13, 2017
Primary CompletionOct 1, 2020
Study CompletionOct 10, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 9.0 years ago

Interventions

Sugammadexdrug

The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.

Placeboother

The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.