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 respirationsOxygen 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
|