Remifentanil and Atropine for Intubation in Neonates (RAIN)

December 26, 2008 updated by: King Saud University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4J9
        • McMaster University NICU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Remifentanil

Atropine

Remifentanil
Drug: Atropine/Remifentanil

Atropine 20mcg/kg

Remifentanil 3mcg/kg
Placebo Comparator: Fentanyl

Atropine

Fentanyl

Succinylcholine
Drug: Fentanyl/Atropine/Succinylcholine

Atropine 20mcg/kg

Fentanyl 2mcg/kg

Succinylcholine 2mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Successful intubation
Time Frame: 15 minutes
15 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to return of spontaneous respirations
Time Frame: 15 minutes
15 minutes
Oxygen saturation
Time Frame: During the procedure up to 15 minutes
During the procedure up to 15 minutes
Heart Rate
Time Frame: During the procedure up to 15 minutes
During the procedure up to 15 minutes
Blood Pressure
Time Frame: During the procedure up to 15 minutes
During the procedure up to 15 minutes
Intubation Condition
Time Frame: 15 minutes post procedure
15 minutes post procedure
Evidence of Trauma
Time Frame: 15 minutes post procedure
15 minutes post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud University

Collaborators

McMaster University

Investigators

  • Principal Investigator: Khalid M Alfaleh, MBBS, MSc, King Saud University
  • Study Director: Karen Choong, FRCPC, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

December 24, 2008

First Submitted That Met QC Criteria

December 26, 2008

First Posted (Estimate)

December 29, 2008

Study Record Updates

Last Update Posted (Estimate)

December 29, 2008

Last Update Submitted That Met QC Criteria

December 26, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAIN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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