Anesthesia for Awake Fiberoptic Intubation

This study is currently recruiting participants.

Verified November 2012 by Klinikum St. Georg gGmbH

Sponsor:

Information provided by (Responsible Party):

Armin Sablotzki, MD, Klinikum St. Georg gGmbH

ClinicalTrials.gov Identifier:

NCT00948350

First received: July 27, 2009

Last updated: November 12, 2012

Last verified: November 2012

History of Changes

Purpose

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	Intervention
Intubation	Procedure: awake intubation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Further study details as provided by Klinikum St. Georg gGmbH:

Primary Outcome Measures:

patients satisfaction with anesthesia [ Time Frame: up to two weeks after hospital admission ] [ Designated as safety issue: No ]
participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcome Measures:

pain after anesthesia [ Time Frame: Change from Baseline in pain after anesthesia at end of hospital stay ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948350

Contacts

Contact: Michael Malcharek, MD	0049-(0)341-9094009	michael.malcharek@sanktgeorg.de
Contact: Armin R Sablotzki, MD, PhD	0049-(0)341-9092570	armin.sablotzki@sanktgeorg.de

Locations

Germany
Klinikum St. Georg gGmbH	Recruiting
Leipzig, Sachsen, Germany, 04129
Contact: Michael Malcharek, MD 0049-(0)341-9094009 michael.malcharek@sanktgeorg.de
Principal Investigator: Michael Malcharek, MD
Sub-Investigator: Birgit Rogos, MD

Sponsors and Collaborators

Klinikum St. Georg gGmbH

Investigators

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

More Information

No publications provided

Responsible Party:	Armin Sablotzki, MD, Prof. Dr. med., Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier:	NCT00948350 History of Changes
Other Study ID Numbers:	EK-BR-34/08-1, Stu08/0041
Study First Received:	July 27, 2009
Last Updated:	November 12, 2012
Health Authority:	Germany: Ethics Commission

Keywords provided by Klinikum St. Georg gGmbH:

cervical instability
awake intubation
laryngeal anesthesia

Additional relevant MeSH terms:

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013

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