Endotracheal IntubationPhase 4RAINNCT00815048
Remifentanil and Atropine for Intubation in Neonates
A Phase 4 study testing Atropine/Remifentanil and Fentanyl/Atropine/Succinylcholine in people with Endotracheal Intubation, run by King Saud University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Atropine/Remifentanil and Fentanyl/Atropine/Succinylcholine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2006to Feb 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Endotracheal Intubation
- Being tested
- Atropine/Remifentanil, Fentanyl/Atropine/Succinylcholine
- Keywords
- Remifentanil, Endotracheal intubation, Premedication, Sedation, Endotracheal Intubation in Neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine/RemifentanilDrug
Atropine 20mcg/kg
Remifentanil 3mcg/kg
Fentanyl/Atropine/SuccinylcholineDrug
Atropine 20mcg/kg
Fentanyl 2mcg/kg
Succinylcholine 2mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Active comparator | Atropine
Remifentanil Receives: Drug: Atropine/Remifentanil |
| Fentanyl | Placebo comparator | Atropine
Fentanyl
Succinylcholine Receives: Drug: Fentanyl/Atropine/Succinylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Successful intubation
Measured: 15 minutes
Secondary outcomes (6)
Time to return of spontaneous respirations
Measured: 15 minutes
Oxygen saturation
Measured: During the procedure up to 15 minutes
Heart Rate
Measured: During the procedure up to 15 minutes
Blood Pressure
Measured: During the procedure up to 15 minutes
Intubation Condition
Measured: 15 minutes post procedure
Evidence of Trauma
Measured: 15 minutes post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2008 (estimated)
- Study startJan 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Investigators
- Khalid M Alfaleh, MBBS, MSc, Principal investigator, King Saud UniversityKaren Choong, FRCPC, Study director, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815048
- Sponsor's protocol ID
- RAIN
- Acronym
- RAIN
- Status last verified
- Dec 2008
- First submitted
- 24 Dec 2008
- Last updated
- 29 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil and Atropine for Intubation in Neonates; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00815048
- Acronym / sponsor ID
- RAIN / RAIN
- Conditions
- Endotracheal Intubation
- Keywords
- Remifentanil, Endotracheal intubation, Premedication, Sedation, Endotracheal Intubation in Neonates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Jan 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 29 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Active comparator | Drug: Atropine/RemifentanilAtropine Remifentanil |
| Fentanyl | Placebo comparator | Drug: Fentanyl/Atropine/SuccinylcholineAtropine Fentanyl Succinylcholine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atropine/RemifentanilAtropine 20mcg/kg Remifentanil 3mcg/kg | Drug | Remifentanil |
| Fentanyl/Atropine/SuccinylcholineAtropine 20mcg/kg Fentanyl 2mcg/kg Succinylcholine 2mg/kg | Drug | Fentanyl |
Primary outcome
Time to Successful intubation
Time frame: 15 minutes
6 secondary outcomes
Time to return of spontaneous respirations
Time frame: 15 minutes
Oxygen saturation
Time frame: During the procedure up to 15 minutes
Heart Rate
Time frame: During the procedure up to 15 minutes
Blood Pressure
Time frame: During the procedure up to 15 minutes
Intubation Condition
Time frame: 15 minutes post procedure
Evidence of Trauma
Time frame: 15 minutes post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khalid M Alfaleh, MBBS, MSc principal investigator
King Saud University
Karen Choong, FRCPC study director
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atropine/Remifentanil and Fentanyl/Atropine/Succinylcholine in people with Endotracheal Intubation, run by King Saud University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Successful intubation (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2008.