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Anesthesia Intubation ComplicationPhase 4NCT01518608

Alfentanil and the Elimination of Sympathetic Responses to Tracheal Intubation During Rapid Sequence Induction of Anesthesia: A Probability-based Approach

A Phase 4 study testing Alfentanil 0.5mg/ml (Rapifen , Janssen-Cilag) in people with Anesthesia Intubation Complication, run by Oslo University Hospital at 2 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Induction of anesthesia: After 3 minutes pre-oxygenation with 100% oxygen, a blinded dose alfentanil (0,10,20,30,40,50 or 60 µg/kg, followed by thiopental 4 mg/kg and rocuronium 0.6 mg/kg will be administered over 15 sec. Laryngoscopy will be performed 40 s. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Anesthesia Intubation Complication
What is being tested?
Alfentanil 0.5mg/ml (Rapifen , Janssen-Cilag)
How many people
84 participants
Where
2 sitesNorway
Study dates
Sep 2009to Oct 2011
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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • ASA I and II patients and admitted for elective surgery.
  • Aged 18-55 years
  • Written informed consent

Who cannot join

  • Body Mass Index (BMI) > 28 Kg/m²
  • Patients with known allergy to study drug
  • Patients with known porphyria
  • Neuromuscular disease or undergoing treatment with drugs known to interfere with neuromuscular transmission.
  • Mallampati class > 2airway anatomy, or anticipated difficulty with mask ventilation or tracheal intubation.
  • Neuromuscular disease
  • Pulmonary disease
  • Cardiovascular disease.

Trial locations and contacts

2 sites in 1 country.

Norway2 sites
  • Oslo University Hospital/ Aker

    Oslo, Akershus, 0514

  • Oslo University Hospital / Aker

    Oslo, 0514

Other trials in Norway

About this study

Induction of anesthesia:

After 3 minutes pre-oxygenation with 100% oxygen, a blinded dose alfentanil (0,10,20,30,40,50 or 60 µg/kg, followed by thiopental 4 mg/kg and rocuronium 0.6 mg/kg will be administered over 15 sec. Laryngoscopy will be performed 40 s. after injection of rocuronium, with the goal being to have the endotracheal tube passed through the patients vocal cords and the cuff inflated within the following 15 s . The investigator performing the tracheal intubation is blinded to the dose of alfentanil administered.

Read more

Blood samples:

As part of the study efficacy, blood samples, will be collected prior to induction and 30 s., 1 min. 3 min. and 5 min postintubation to determine blood concentrations of alfentanil and catecholamines.

Read the detailed description

Introduction:

Autonomic responses (blood pressure and heart rate increases) secondary to tracheal intubation are probably not harmful to healthy individuals(1). However, in certain groups of patients (cardiac/neurosurgical/ophthalmic surgery), strict control of these responses during anesthesia may add to the safety of patient care (2-6).

Traditionally, rapid sequence induction (RSI) of anesthesia is performed with combined administration of pentothal and suxamethonium. Significant increases in blood pressure and heart rate will be observed in most patients when this drug regimen is used(7-9). Opioid drugs may obtund autonomic responses to tracheal stimulation(10), but at present there is no consensus regarding the use of opioids as an integral part of the RSI of anesthesia.

AIMS \& OBJECTIVES:

  • Define guidelines for proper care of cardiac/neurosurgical/eye surgery patients during induction of anesthesia when rapid airway control is needed.
  • Determine the dose of alfentanil needed to prevent blood pressure and heart rate increases > 10% secondary to tracheal intubation performed in a rapid-sequence fashion (intubation completed within 70 s after start of drug administration: alfentanil-pentothal 4 mg/kg-rocuronium 0.6 mg/kg).
  • Determine the optimal dose of alfentanil to obtain perfect conditions for tracheal intubation in healthy surgical patients when laryngoscopy is initiated within 55 s after start of drug administration (alfentanil-pentothal 4 mg/kg-rocuronium 0,6 mg/kg).

Induction of anesthesia:

After 3 min pre-oxygenation with 100% oxygen, a blinded dose of alfentanil (0, 10, 20, 30, 40, 50 or 60 mcg/kg), followed by thiopental 4 mg/kg and rocuronium 0.6 mg/kg will be administered over 15 s. Cricoid pressure will be applied when the patient is unconscious.

Laryngoscopy and intubation:

Laryngoscopy will be performed 40 s after injection of rocuronium, with the goal being to have the endotracheal tube passed through the patients vocal cords and the cuff inflated within the following 15 s. The investigator performing the tracheal intubation will be blinded to the dose of alfentanil administered.

Maintenance of anesthesia:

The study ends 5 min post intubation. At this time sevoflurane and fentanyl will be administered according to the patient's needs. Ventilation will be adjusted to pCO2-values in the range 4.5-6 kPa, and body temperature maintained at > 36 degree ºC with a forced-air warmer.

Monitoring:

Routine monitoring of blood pressure, ECG, and pulse oximetry, according to standard of anaesthesia, approved by the Society of the Norwegian Anaesthesiologists. An arterial line will be inserted in one of the radial arteries for accurate beat-to-beat recording of blood pressure and heart rate, and for collection of blood samples.

Statistical analysis plan:

In the present study a nonlinear logistic regression analysis will be used to determine the optimal dose of alfentanil based on the success rates of optimal blood pressure control (blood pressure increase < 10%)and the success rates of perfect intubation conditions in all alfentanil dose groups.

Being tested
Alfentanil 0.5mg/ml (Rapifen , Janssen-Cilag)
Keywords
Alfentanil, Tracheal intubation, Rapid sequence induction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alfentanil 0.5mg/ml (Rapifen , Janssen-Cilag)Drug

    Induction dose(0µg/kg,10µg/kg,20µg/kg,30µg/kg,40µg/kg,50µg/Kg,and 60µg/kg) 12 patients in each dose group.

    Pentothal 4mg/kg Rocuronium 0.6 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alfentanil and blockage of sympathetic responses: A dose-response study.

    Effectivness of controling Blood pressure during intubation

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2012 (estimated)
  2. Study startSep 2009
  3. Primary completionSep 2011
  4. Study completionOct 2011

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01518608
Sponsor's protocol ID
29237403/SMR-1651
Status last verified
Jan 2012
First submitted
25 Aug 2011
Last updated
26 Jan 2012
Results posted
No
Data monitoring committee
No

Publications

  • Abou-Arab MH, Feiner JR, Spigset O, Heier T. Alfentanil during rapid sequence induction with thiopental 4 mg/kg and rocuronium 0.6 mg/kg: tracheal intubation conditions. Acta Anaesthesiol Scand. 2015 Nov;59(10):1278-86. doi: 10.1111/aas.12584. Epub 2015 Jul 14.

    PubMed 26176994

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Alfentanil 0.5mg/ml (Rapifen , Janssen-Cilag) in people with Anesthesia Intubation Complication, run by Oslo University Hospital at 2 sites in Norway.

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 3 inclusion and 8 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 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. 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. 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?

Alfentanil and blockage of sympathetic responses: A dose-response study. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01518608, which also lists 1 linked publication.

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 26 Jan 2012.

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