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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-01-31

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.

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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 one hour after intubation.

Conditions

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Postoperative Complications Intubation; Difficult or Failed Intubation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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\*√\[30(100-30/n) + 10(100- 10/n)\]

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Caregivers

A study nurse will prepare sealed envelopes with the study-arm specified inside. Patients fullfilling the inclusion criteria will be invited to participate. Patients will be blinded for study arm. Intubation will be performed by trained intubators. However, due to the medications possible risk for rest-curarisation, the anesthesia personnel will possibly be able to detect intervention. However, care personnel collecting data will not know which study arm the patient belongs to.

Study Groups

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Lidocaine spray on the glottis

Lidocaine 20 mgl/ml- 4,4 ml will be sprayed on the glottis. Ventilation for 90 sek, intubation

Group Type ACTIVE_COMPARATOR

Lidocaine topical

Intervention Type DRUG

Comparing lidocaine spray and muscle relaxing medication

Muscle relaxing medication

Rocuronium 0,6 mg/kg administered intravenous. Ventilation for 2.5 minutes (150seconds), intubation

Group Type ACTIVE_COMPARATOR

Lidocaine topical

Intervention Type DRUG

Comparing lidocaine spray and muscle relaxing medication

Interventions

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Lidocaine topical

Comparing lidocaine spray and muscle relaxing medication

Intervention Type DRUG

Other Intervention Names

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Rocurinoum 0.6 mg/kg intravenous

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No