Anesthesia for Awake Fiberoptic Intubation

Not Applicable

Completed

• Conditions: Intubation
• Interventions: Procedure: awake intubation

• Registration Number: NCT00948350
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-07-27
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-17
• Last Update Posted: 2015-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
translaryngeal injection	awake intubation	translaryngeal injection of local anesthetics before the awake intubation
spray as you go	awake intubation	local anesthetics are given through the fiberoptic during awake intubation

Primary Outcome Measures

Name	Time	Method
patients satisfaction with anesthesia	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

Name	Time	Method
pain after anesthesia	Change from Baseline in pain after anesthesia at end of hospital stay

Trial Locations

Locations (1)

Klinikum St. Georg gGmbH; 🇩🇪 Leipzig, Sachsen, Germany