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

Ostfold University College

Status: Completed

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

Treatments: Drug: Lidocaine topical

Study type: Interventional

Funder types: Other

Identifiers

NCT05614609

Sykehuset Østfold

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Lidocaine spray on the glottis

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine topical

Muscle relaxing medication

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine topical