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

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Aker
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01518608
First received: August 25, 2011
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

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


Enrollment: 84
Study Start Date: September 2009
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01518608     History of Changes
Other Study ID Numbers: 29237403/SMR-1651
Study First Received: August 25, 2011
Last Updated: January 25, 2012
Health Authority: Norway: Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 23, 2014