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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05334017
Other study ID # 89303200
Secondary ID 2021-000691-11H-
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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