CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 45 enrolled
Drug / intervention
Rocuronium +1 moredrug
Likely dose
Rocuronium 0.6 mg/Kgfrom 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/NCT01749501
NCT01749501Phase 4Completed

Premedication for Non-Emergency Endotracheal Intubation In the NICU

Martin Espinosa, MD·interventional·Posted Dec 13, 2012·Updated Nov 30, 2017

In Brief

A Phase 4 clinical trial evaluating Rocuronium and Placebo for Respiratory Distress Syndrome. Completed, enrolled 45 participants.

Detailed Summary

Those infants who received the muscle relaxation in combination with the vagolytic (reduce vagus nerve impulses) and pain medication will have reduced time to successful intubation (placement of tube into the lungs), a decrease in the number of attempts, and better intubation conditions reported by the practitioner. The objectives of the study include: 1.) Does the medication protocol outlined in this study provide optimal intubation conditions? (i.e.good jaw relaxation, open and immobile vocal cords and suppression of gag reflex) 2.) Does the addition of a muscle relaxant prior to intubation contribute to less attempts and achieving successful intubation as opposed to neonates who do not receive the muscle relaxant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 13, 2012
Enrollment StartJan 1, 2011
Primary CompletionDec 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 13.6 years ago

Interventions

Rocuroniumdrug

0.6 mg/Kg once

Placeboother

Normal saline same amt as 0.6mg/kg of study drug