Anesthesia for Awake Fiberoptic Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00948350
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : April 20, 2015
Information provided by (Responsible Party):
Armin Sablotzki, MD, Klinikum St. Georg gGmbH

Brief Summary:
This is a prospective, comparative, randomized, monocentric, clinical open study, to compare two anesthesia techniques (translaryngeal injection vs. spray as you go) in patients with cervical instability with regard to technical modalities and quality of fiberoptic awake intubation.

Condition or disease Intervention/treatment Phase
Intubation Procedure: awake intubation Not Applicable

Detailed Description:

In patients with cervical instability anesthesia induction and conventional intubation are associated with the risk of neurological harm. Therefore the method of choice for anesthesia induction is the fiberoptic awake intubation. This method allows to place the ventilation tube without movement of the cervical spinal cord. This procedure is very uncomfortable for the patient and needs the application of topic and/or systemic anesthetics.

With this clinical study we will compare two established techniques for local laryngeal anesthesia with regard to the quality of technical modalities and postoperative outcome.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Anesthesia for Awake Fiberoptic Intubation in Patients With Cervical Instability - Comparison of Translaryngeal Injection and "Spray as You go"-Technique
Study Start Date : January 2009
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: translaryngeal injection
translaryngeal injection of local anesthetics before the awake intubation
Procedure: awake intubation
two anesthesia techniques
Active Comparator: spray as you go
local anesthetics are given through the fiberoptic during awake intubation
Procedure: awake intubation
two anesthesia techniques

Primary Outcome Measures :
  1. patients satisfaction with anesthesia [ Time Frame: up to two weeks after hospital admission ]
    participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcome Measures :
  1. pain after anesthesia [ Time Frame: Change from Baseline in pain after anesthesia at end of hospital stay ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients with cervical instability undergoing elective decompression of cervical spine

Exclusion Criteria:

  • patient refused participation
  • contraindications for awake intubation techniques (e.g. nasal bleeding, anatomical disorders)
  • patient under alcohol or drugs
  • emergency surgery

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 identifier (NCT number): NCT00948350

Klinikum St. Georg gGmbH
Leipzig, Sachsen, Germany, 04129
Sponsors and Collaborators
Klinikum St. Georg gGmbH
Study Chair: Armin R Sablotzki, MD Clinics of Anesthesiology, Critical care and Pain Therapy
Principal Investigator: Michael Malcharek, MD Clinic of Anesthesiology, Dept. Neuroanesthesia and Neuromonitoring

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Armin Sablotzki, MD, Prof. Dr. med., Klinikum St. Georg gGmbH Identifier: NCT00948350     History of Changes
Other Study ID Numbers: EK-BR-34/08-1
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: April 20, 2015
Last Verified: April 2015

Keywords provided by Armin Sablotzki, MD, Klinikum St. Georg gGmbH:
cervical instability
awake intubation
laryngeal anesthesia

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs