Xylometazoline and Cocaine for Nasal Vasoconstriction

Epistaxis Clinical Trial

Official title:

Comparison of the Effect of Xylometazoline and Cocaine on Epistaxis When Administered as Local Vasoconstrictors Prior to Nasal Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05334017
• Other study ID #: 89303200
• Secondary ID: 2021-000691-11H-
• Status: Completed
• Phase: Phase 4
• Start date: September 8, 2022
• Est. completion date: March 22, 2023

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 22, 2023
• Est. primary completion date: March 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epistaxis

Intervention

Drug:
• Xylometazoline 0,1%
1 ml of 0,1% xylometazoline diluted with 1 ml of 0,9% isotonic saline solution given as a nasal spray
• Cocaine 4%
2 ml of 4% cocaine given as a nasal spray

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Copenhagen University Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding score	Evaluation of epistaxis measured on a predefined scale of 0-3: 0. No sign of bleeding; Blood only on the tracheal tube; Pooling of blood in the pharynx; Bleeding to the extent that it complicates intubation	Immediately following nasal intubation
Secondary	Qualitative measurements of cocaine's main metabolite benzoylecgonine in saliva	For cocaine-group only, saliva samples will be obtained and analyzed on the DrugTest 5000 machine used by the Danish Police Force in order to evaluate pharmacokinetics.	Immediately prior to nasal intubation, 60 minutes after administration of cocaine and 24 hours after administration of cocaine.
Secondary	Quantitative measurements of cocaine in whole blood.	In the cocaine group only, blood samples will be drawn and analyzed for the presence of cocaine in order to evaluate pharmacokinetics.	Immediately prior to nasal intubation, 60 minutes after administration of cocaine and 24 hours after administration of cocaine.