Clinical trial NCT05334017: Xylometazoline and Cocaine for Nasal Vasoconstriction
Official title: Comparison of the Effect of Xylometazoline and Cocaine on Epistaxis When Administered as Local Vasoconstrictors Prior to Nasal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epistaxis
Keywords: nasal intubation
vasoconstriction
epistaxis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to compare xylometazoline and cocaine's effect on minimizing epistaxis when administered as a local vasoconstrictor prior to nasal intubation.

The investigators hypothesize that there will be a lower bleeding score in the group receiving xylometazoline as compared with the group receiving cocaine.

Detailed description: 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. Upon intubation the nasal mucosa must be sufficiently lubricated and decongested in order to minimize the risk of epistaxis. For this purpose several topical agents are suggested, the most common being adrenaline, cocaine and oxymetazoline/xylometazoline in varying combinations and dosages. As such, no broad consensus or guidelines currently exist on a single recommended drug for the prevention of epistaxis induced by nasal intubation.

In 1990 Katz et. al performed a study comparing three interventions: cocaine, lidocaine with epinephrine and oxymetazoline in regard to the prevention of epistaxis on nasotracheal intubation. This study included 14 patients in each of their three groups and the authors concluded that oxymetazoline and cocaine were equally effective. However, due to their limited sample size that study was clearly inconclusive, and the investigators wish to repeat such a comparison.

The trial drug xylometazoline is commonly used in Danish operating rooms under the registered trademark Zymelin. It is an adrenergic drug typically used for decongestion of the nose and its local vasoconstrictive effect occurs after a few minutes and lasts 10-12 hours. The drug is readily available without prescription and in theory the patient could administer this themselves on their way to surgery. Oxymetazoline used by Katz et. al and xylometazoline used in Danish hospitals have similar decongestive effects as oxymetazoline is a derivative of xylometazoline. The two drugs share pharmacodynamics varying only on receptor subtype affinity in their direct action on alpha-adrenergic receptors in the arterioles of the nasal mucosa. Both drugs result in vasoconstriction that leads to decreased blood flow and thereby decongests the nose.

The second trial drug cocaine is also routinely used. It is a magistral formula used especially due to its unique combination of both vasoconstrictive and analgesic properties. It is a potent vasoconstrictor through its ability to inhibit the reuptake and metabolism of catecholamines, which then in greater concentration produce adrenergic effects. Uniquely cocaine also binds to and blocks axonal membrane sodium channels, thus interfering with the propagation of action potentials and thereby exerting an analgesic effect. When administered in doses thought to avoid systemic effects, cocaine is a safe local anesthetic agent. The recommended dosage varies considerably throughout the literature with safe doses ranging between 1.5-3.0 mg/kg.

The investigators wish to compare the effects of xylometazoline and cocaine regarding their prevention of epistaxis during and immediately after nasal intubation.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Scheduled for nasal intubation
* Proficient in spoken and written Danish

Exclusion Criteria:

* Intubation to be done on awake patient
* Pregnancy

  * Women of childbearing potential must produce a negative hCG urine stix to participate
* Known symptomatic coronary artery disease

  * As declared by patient or noted in the patient's file
* Untreated hypertension

  * As declared by patient or noted in the patient's file
  * Not taking antihypertension drugs
* Hypersensitivity to the active substance or to any of the excipients of Zymelin

  * As declared by patient or noted in the patient's file
* Closed-angle glaucoma

  * As declared by patient or noted in the patient's file

Primary outcomes:
measure: Bleeding score
timeFrame: Immediately following nasal intubation
Secondary outcomes:
measure: Qualitative measurements of cocaine's main metabolite benzoylecgonine in saliva
timeFrame: Immediately prior to nasal intubation, 60 minutes after administration of cocaine and 24 hours after administration of cocaine.
measure: Quantitative measurements of cocaine in whole blood.
timeFrame: Immediately prior to nasal intubation, 60 minutes after administration of cocaine and 24 hours after administration of cocaine.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Mo Haslund Larsen, MD
role: PRINCIPAL_INVESTIGATOR
References: