Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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 two hours after intubation.

Official Title
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Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial in a Norwegian Hospital

Conditions
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Postoperative Complications, Intubation; Difficult or Failed, Intubation Complication

Intervention / Treatment
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* Drug: Lidocaine topical


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Block randomization through randomization.com. Proprotion of hoarseness grade-2-or-3 = 30 % in spray and 10 % in rocuronium. 59 patients in each arm. sig p <= ,05, H0 = 0 + 1,96*√[30(100-30)n + 10(100-10)/n] Gitt power >= ,80 , HAlt = (30-10) - 0,84*√[30(100-30/n) + 10(100- 10/n)]
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine spray on the glottis<br>Lidocaine 20 mgl/ml- 4,4 ml will be sprayed on the glottis. Ventilation for 90 sek, intubation | Drug: Lidocaine topical<br>* Comparing lidocaine spray and muscle relaxing medication<br>* Other names: Rocurinoum 0.6 mg/kg intravenous;|
| Active Comparator: Muscle relaxing medication<br>Rocuronium 0,6 mg/kg administered intravenous. Ventilation for 2.5 minutes (150seconds), intubation | Drug: Lidocaine topical<br>* Comparing lidocaine spray and muscle relaxing medication<br>* Other names: Rocurinoum 0.6 mg/kg intravenous;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of hoarseness 2 hours after extubation | Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation conditions | Cormack & Lehane four degrees | Before intubation | 
| Number of intubation attempts | Number | At intubation | 
| Number of patients needing extra equipment for intubating | bourgie, c-mac, other | At intubation | 
| Proportion of patients who cough when spraying | yes/no | At intubation | 
| Proportion of patients with normal anatomy in upper airways | yes/no | At intubation | 
| Blood pressure changes during intubation | Blood pressure before and 2 minutes after intubation | at intubation | 
| Heart rate changes during intubation | Heart rate before and 2 minutes after intubation | at intubation | 
| Proportion of patients who cough on tube at extubation | yes/no | At extubation | 
| Proportion of patients with blood on tube after extubation | yes/no | At extubation | 
| Degree of hoarsness 24 and 48 hours after extubation | Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia | 2-48 hours | 
| Proportion of patients reporting different degrees of sore throat at 2, 24 and 48 hours after extubation | 0=no, 1=mild, 2=moderate, constant pain when swallowing, 3=severe pain needing analgesia | 2-48 hours |