Anesthesia Intubation Complication Clinical Trial
Official title:
Alfentanil and the Elimination of Sympathetic Responses to Tracheal Intubation During Rapid Sequence Induction of Anesthesia: A Probability-based Approach
Verified date | January 2012 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | October 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - ASA I and II patients and admitted for elective surgery. - Aged 18-55 years - Written informed consent Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital / Aker | Oslo | |
Norway | Oslo University Hospital/ Aker | Oslo | Akershus |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | University Hospital, Aker |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alfentanil and blockage of sympathetic responses: A dose-response study. | Effectivness of controling Blood pressure during intubation | 2 years | Yes |
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