Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial in a Norwegian Hospital
Overview
- Phase
- Not Applicable
- Intervention
- Lidocaine topical
- Conditions
- Postoperative Complications
- Sponsor
- Ostfold University College
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Degree of hoarseness 1 hour after extubation
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
Few studies have compared different methods for optimalizing intubation conditions in general anesthesia. This randomized controlled trial will compare two different methods for intubation in general anesthesia in gastro- or gynecological procedures.
Detailed Description
In general anesthesia, it is neccessary to secure the airways with an endotracheal tube. There is no international consensus on how intubation is most efficiently conducted. A cochrane review compared using muscular relaxing medication versus not using blocks for intubation. Primary outcomes were intubation conditions and discomfort in upper airways. The authors concluded that research is limited, and that further research is needed. No studies have compared local anesthetic spray on the glottis and muscular relaxing medication in intubation, focusing on discomfort in upper airways. The null-hypothesis of this study is that there is no difference in upper airway discomfort when using local anesthetic spray or muscular relaxing medication. The study will have a randomized controlled design, randomizing patients undergoing gastro- or gynecological procedures in general anesthesia to receiving either rocuronium (muscle relaxing medication) intravenous, or lidocain spray on the glottis before intubation. The primary outcome is postoperativ hoarseness one hour after intubation.
Investigators
Ann-Chatrin Leonardsen
Professor
Ostfold Hospital Trust
Eligibility Criteria
Inclusion Criteria
- •ASA (American Association of Anesthesiologists Classification system for physical status) I-III
- •Understand and can express themselves in Norwegian
- •Able to give informed consent to participate
Exclusion Criteria
- •Cave lidocain and/or muscle relaxing medication
- •BMI above 40
- •Anticipated difficult intubation
- •Need for ventricular tube
- •Pathology or malformations in upper airways
Arms & Interventions
Lidocaine spray on the glottis
Lidocaine 20 mgl/ml- 4,4 ml will be sprayed on the glottis. Ventilation for 90 sek, intubation
Intervention: Lidocaine topical
Muscle relaxing medication
Rocuronium 0,6 mg/kg administered intravenous. Ventilation for 2.5 minutes (150seconds), intubation
Intervention: Lidocaine topical
Outcomes
Primary Outcomes
Degree of hoarseness 1 hour after extubation
Time Frame: 1 hours
Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia
Secondary Outcomes
- Proportion of patients who cough on tube at extubation(At extubation)
- Number of patients needing extra equipment for intubating(At intubation)
- Proportion of patients who cough when spraying(At intubation)
- Intubation conditions(Before intubation)
- Number of intubation attempts(At intubation)
- Proportion of patients with normal anatomy in upper airways(At intubation)
- Heart rate changes during intubation(at intubation)
- Proportion of patients with blood on tube after extubation(At extubation)
- Blood pressure changes during intubation(at intubation)
- Degree of hoarsness 24 and 48 hours after extubation(2-48 hours)
- Proportion of patients reporting different degrees of sore throat at 2, 24 and 48 hours after extubation(2-48 hours)