Alfentanil and the Elimination of Sympathetic Responses to Tracheal Intubation During Rapid Sequence Induction of Anesthesia: A Probability-based Approach
1 other identifier
interventional
84
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2009
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Posted
Study publicly available on registry
January 26, 2012
CompletedJanuary 26, 2012
January 1, 2012
2 years
August 25, 2011
January 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alfentanil and blockage of sympathetic responses: A dose-response study.
Effectivness of controling Blood pressure during intubation
2 years
Interventions
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
Eligibility Criteria
You may qualify if:
- ASA I and II patients and admitted for elective surgery.
- Aged 18-55 years
- Written informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- University Hospital, Akercollaborator
Study Sites (2)
Oslo University Hospital/ Aker
Oslo, Akershus, 0514, Norway
Oslo University Hospital / Aker
Oslo, 0514, Norway
Related Publications (1)
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.
PMID: 26176994DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tom Heier, MD, Phd.
University of Oslo
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2011
First Posted
January 26, 2012
Study Start
September 1, 2009
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
January 26, 2012
Record last verified: 2012-01