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When performed by trained personnel nasotracheal intubation is a safe and effective technique for attaining a secure airway in preparation for surgery of the head and neck. The procedure can be deemed necessary due to the nature of the surgical procedure or considerations in regard to the patient's comorbidities. For a certain group of patients with expected difficult airways, the procedure is done whilst they are awake and aided by fiberoptics.
For these awake patients, extra precautions must be taken to ensure the procedure is conducted with minimal pain and discomfort. The pain and discomfort arises from the mechanical manipulation of the nasal mucosa and can be alleviated in part by means of topical analgesia as well as through decongestion, providing more space within the nasal cavity. For these purposes, several drugs in varying combinations and dosages are used, but no single drug choice is universally recommended.
Cocaine is one of these appropriate drugs. It is a magistral formula used especially due to its unique combination of both vasoconstrictive and analgesic properties. Concerns have though been raised regarding cocaine's potential toxicity and alternative medications are continuously sought after.
A combination of lidocaine and xylometazoline can also be used for preparation of the nose prior to awake nasal fiberoptic intubation. Lidocaine contributes with its analgesic effect whilst xylometazoline functions as the vasoconstrictor.
The investigators wish to compare the analgesic effects of cocaine and lidocaine/phenylephrine to each other and saline when subjectively scored on a visual analogue scale of 0-100 mm immediately after simulated awake nasal intubation on healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cocaine | Active Comparator | 2 mL 4% cocaine hydrochloride |
|
| Xylometazoline and lidocaine | Active Comparator | 1.5 mL of 4% lidocaine and 0.5 mL 0.1% xylometazoline |
|
| Saline | Placebo Comparator | 2 ml of 0,9% saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cociane hydrochloride 4% | Drug | 2 mL of 4% cocaine |
| |
| Lidocaine 4% |
| Measure | Description | Time Frame |
|---|---|---|
| Pain regarding the procedure | Self reported pain on a visual analogue scale of 0-100 mm | Immediately following the procedure of 10 cm insertion of a 6.0 nasal endotracheal tube |
| Measure | Description | Time Frame |
|---|---|---|
| Pain regarding the procedure | Self reported pain on a visual analogue scale of 0-100 mm | One minute after the procedure of insertion of a 6.0 nasal endotracheal tube |
| Volume | Volume within both nasal cavities measured with acoustic rhinometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mo H Larsen, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40346884 | Derived | Larsen MH, Rosenkrantz O, Knudsen RL, Hesselfeldt R, Hilberg O, Siersma V, Heiberg J, Rasmussen LS, Isbye D. Analgesic Effect of Cocaine and Lidocaine/Xylometazoline in Healthy Volunteers Undergoing Awake Nasal Intubation: A Randomized Controlled Crossover Trial. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70056. doi: 10.1111/aas.70056. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Drug |
1.5 mL of 4% lidocaine |
|
| Xylometazoline 0.1% | Drug | 0.5 mL of xylometazoline 0.1% |
|
| Saline 0.9% | Drug | 2 mL of saline 0.9% |
|
| 5 minutes before drug administration and 1, 3, 5, 7 and 9 minutes after drug administration |
| Fiberoptic endoscopy | Preferred nasal cavity based on a comparison of the degree of vasoconstriction of the nasal mucosa evaluated by fiberoptic endoscopy assessed by ENT-specialist | Fiberoptic endoscopy performed 10 minutes before drug administraion and 10 minutes after drug administration |
| Drug test detection | Concentraion of cocaine and cocaine's main metabolite benzoylecgonine in blood and saliva samples respectively | 15 minutes before drug administration and 1, 2 and 3 hours after drug administration |
| Heart rate | Measurement of heart rate | 5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration |
| Blood pressure | Measurement of mean arterial blood pressure | 5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration |
| Patient-centred questions | The degree of discomfort and unpleasentness of taste of the drug administration on a scale of 1-10 and whether they felt exaltation after drug administration. | 15 minutes after drug administration |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |