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.
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
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.
- Conditions
- Anesthesia Intubation Complication
- 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.
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.
- First posted26 Jan 2012 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Aker
- Responsible party
- Sponsor
- Investigators
- Tom Heier, MD, Phd., Study director, University of Oslo
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alfentanil and the Elimination of Sympathetic Responses to Tracheal Intubation During Rapid Sequence Induction of Anesthesia: A Probability-based Approach
- ClinicalTrials.gov ID
- NCT01518608
- Acronym / sponsor ID
- 29237403/SMR-1651
- Conditions
- Anesthesia Intubation Complication
- Keywords
- Alfentanil, Tracheal intubation, Rapid sequence induction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Aker
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 26 Jan 2012 (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.
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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I and II patients and admitted for elective surgery.
- Aged 18-55 years
- Written informed consent
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Alfentanil 0.5mg/ml (Rapifen , Janssen-Cilag)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 | Drug | – |
Primary outcome
Alfentanil and blockage of sympathetic responses: A dose-response study.
Time frame: 2 years
Effectivness of controling Blood pressure during intubation
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 26 Jan 2012.
- Derived from this study: PubMed 26176994Abou-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.
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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.
Tom Heier, MD, Phd. study director
University of Oslo
2 sites in 1 country: see every site and its status.
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.