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

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ClinicalTrials.gov Identifier: NCT01518608
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : January 26, 2012
Sponsor:
Collaborator:
University Hospital, Aker
Information provided by (Responsible Party):
Oslo University Hospital

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.


Condition or disease Intervention/treatment Phase
Anesthesia Intubation Complication Drug: Alfentanil 0.5mg/ml (Rapifen , Janssen-Cilag) Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Alfentanil and the Elimination of Sympathetic Responses to Tracheal Intubation During Rapid Sequence Induction of Anesthesia: A Probability-based Approach
Study Start Date : September 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources


Intervention Details:
    Drug: 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



Primary Outcome Measures :
  1. Alfentanil and blockage of sympathetic responses: A dose-response study. [ Time Frame: 2 years ]
    Effectivness of controling Blood pressure during intubation



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518608


Locations
Norway
Oslo University Hospital/ Aker
Oslo, Akershus, Norway, 0514
Oslo University Hospital / Aker
Oslo, Norway, 0514
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Aker
Investigators
Study Director: Tom Heier, MD, Phd. University of Oslo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01518608     History of Changes
Other Study ID Numbers: 29237403/SMR-1651
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: January 26, 2012
Last Verified: January 2012

Keywords provided by Oslo University Hospital:
Alfentanil
Tracheal intubation
Rapid sequence induction

Additional relevant MeSH terms:
Alfentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics