Remifentanil and Atropine for Intubation in Neonates

Phase 4

Completed

• Conditions: Endotracheal Intubation
• Interventions: Drug: Atropine/Remifentanil; Drug: Fentanyl/Atropine/Succinylcholine

• Registration Number: NCT00815048
• Lead Sponsor: King Saud University

Brief Summary

The investigators hypothesize that the use of a combination of Atropine and Remifentanil will safely facilitate non emergent intubation procedure as effectively as the protocol of Atropine, Fentanyl, and Succinylcholine.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2008-12
• Study First Submitted: 2008-12-24
• Study First Submitted QC: 2008-12-26
• Last Update Submitted: 2008-12-26
• Study First Posted: 2008-12-29
• Last Update Posted: 2008-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Hemodynamically stable neonates of any gestational age admitted to the Neonatal Intensive Care Unit at McMaster Children's Hospital requiring an elective endotracheal intubation was anticipated.

Exclusion Criteria

• Urgent intubations
• Cyanotic congenital heart lesions
• Anticipated difficult airway
• Concurrent or recently administered (within 3 hours of the procedure) intravenous opioid infusions
• Pre-existing hyperkalemia
• Family history of malignant hyperthermia
• Prior enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remifentanil	Atropine/Remifentanil	Atropine Remifentanil
Fentanyl	Fentanyl/Atropine/Succinylcholine	Atropine Fentanyl Succinylcholine

Primary Outcome Measures

Name	Time	Method
Time to Successful intubation	15 minutes

Secondary Outcome Measures

Name	Time	Method
Time to return of spontaneous respirations	15 minutes
Oxygen saturation	During the procedure up to 15 minutes
Heart Rate	During the procedure up to 15 minutes
Blood Pressure	During the procedure up to 15 minutes
Intubation Condition	15 minutes post procedure
Evidence of Trauma	15 minutes post procedure

Trial Locations

Locations (1)

McMaster University NICU; 🇨🇦 Hamilton, Ontario, Canada