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Remifentanil and Atropine for Intubation in Neonates

Information source: King Saud University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endotracheal Intubation

Intervention: Atropine/Remifentanil (Drug); Fentanyl/Atropine/Succinylcholine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: King Saud University

Official(s) and/or principal investigator(s):
Khalid M Alfaleh, MBBS, MSc, Principal Investigator, Affiliation: King Saud University
Karen Choong, FRCPC, Study Director, Affiliation: McMaster University

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.

Clinical Details

Official title: Remifentanil and Atropine for Intubation in Neonates; a Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Time to Successful intubation

Secondary outcome:

Time to return of spontaneous respirations

Oxygen saturation

Heart Rate

Blood Pressure

Intubation Condition

Evidence of Trauma

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

McMaster University NICU, Hamilton, Ontario L8S 4J9, Canada
Additional Information

Starting date: January 2006
Last updated: December 26, 2008

Page last updated: August 23, 2015

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