Premedication for Non-Emergency Endotracheal Intubation In the NICU

Phase 4

Completed

• Conditions: Respiratory Distress Syndrome
• Interventions: Other: Placebo; Drug: Rocuronium

• Registration Number: NCT01749501
• Lead Sponsor: Martin Espinosa, MD

Brief 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.

Detailed Description

The investigators project will study two different strategies of pre-medication in an attempt to eliminate the pain and discomfort associated with the elective intubation procedure. The study will be blinded and patients will be randomized in two different arms according to gestational age and identified by study number for pre-medication protocols. Demographic as well as study information prior, during and post intubation attempt will be recorded and closely monitored. Each patient will be monitored for study purposes for at least 24 hours after intubation attempt to record any potential side effects of the medication. The investigators plan to have a data safety monitoring board established composed of three pediatric doctors / specialists not associated with this study.

The response of paralysis, onset and duration will be assessed clinically. Onset of muscle relaxation will be described as the absence of spontaneous movements and flaccidity, measured in seconds from the end of the medication administration. Duration of paralysis will be determined by the difference in time from the onset of paralysis to the return of spontaneous movements and pre-intubation tone

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-13
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Results First Submitted: 2015-06-02
• Results First Submitted QC: 2015-06-02
• Results First Posted: 2015-06-22
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Rocuronium	Rocuronium	0.6 mg/kg once

Primary Outcome Measures

Name	Time	Method
Present the Percentage of Participants With an Excellent Ease of Intubation Rating	24 hours after intubation period	percentage of participants with an excellent ease of intubation rating based on Scale of 1-4 (1 Being Excellent, 4 Being Poor),"

Secondary Outcome Measures

Name	Time	Method
Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded.	24 hours after intubation procedure