Xylometazoline and Cocaine for Nasal Vasoconstriction

NCT ID: NCT05334017

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-08
• Study Completion Date: 2023-03-22

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.

Conditions

Epistaxis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Xylometazoline

Xylometazoline 0,1% as nasal solution given immediately prior to nasal intubation

Group Type: ACTIVE_COMPARATOR

Xylometazoline 0,1%

Intervention Type: DRUG

1 ml of 0,1% xylometazoline diluted with 1 ml of 0,9% isotonic saline solution given as a nasal spray

Cocaine

Cocaine 4% as nasal solution given immediately prior to nasal intubation

Group Type: ACTIVE_COMPARATOR

Cocaine 4%

Intervention Type: DRUG

2 ml of 4% cocaine given as a nasal spray

Interventions

Xylometazoline 0,1%

1 ml of 0,1% xylometazoline diluted with 1 ml of 0,9% isotonic saline solution given as a nasal spray

Intervention Type: DRUG

Cocaine 4%

2 ml of 4% cocaine given as a nasal spray

Intervention Type: DRUG

Other Intervention Names

Zymelin; Cocaine hydrochloride 4%

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Mo Haslund Larsen

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mo Haslund Larsen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet, Copenhagen University Hospital

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

2021-000691-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H-21028051

Identifier Type: OTHER

Identifier Source: secondary_id

89303200

Identifier Type: -

Identifier Source: org_study_id