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Xylometazoline and Cocaine for Nasal Vasoconstriction

Primary Purpose

Epistaxis

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Xylometazoline 0,1%
Cocaine 4%
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epistaxis focused on measuring nasal intubation, vasoconstriction, epistaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet, Copenhagen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Xylometazoline

Cocaine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 12, 2022
Last Updated
March 24, 2023
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05334017
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
March 21, 2023 (Actual)
Study Completion Date
March 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis
Keywords
nasal intubation, vasoconstriction, epistaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xylometazoline
Arm Type
Active Comparator
Arm Description
Xylometazoline 0,1% as nasal solution given immediately prior to nasal intubation
Arm Title
Cocaine
Arm Type
Active Comparator
Arm Description
Cocaine 4% as nasal solution given immediately prior to nasal intubation
Intervention Type
Drug
Intervention Name(s)
Xylometazoline 0,1%
Other Intervention Name(s)
Zymelin
Intervention Description
1 ml of 0,1% xylometazoline diluted with 1 ml of 0,9% isotonic saline solution given as a nasal spray
Intervention Type
Drug
Intervention Name(s)
Cocaine 4%
Other Intervention Name(s)
Cocaine hydrochloride 4%
Intervention Description
2 ml of 4% cocaine given as a nasal spray
Primary Outcome Measure Information:
Title
Bleeding score
Description
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
Time Frame
Immediately following nasal intubation
Secondary Outcome Measure Information:
Title
Qualitative measurements of cocaine's main metabolite benzoylecgonine in saliva
Description
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.
Time Frame
Immediately prior to nasal intubation, 60 minutes after administration of cocaine and 24 hours after administration of cocaine.
Title
Quantitative measurements of cocaine in whole blood.
Description
In the cocaine group only, blood samples will be drawn and analyzed for the presence of cocaine in order to evaluate pharmacokinetics.
Time Frame
Immediately prior to nasal intubation, 60 minutes after administration of cocaine and 24 hours after administration of cocaine.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mo Haslund Larsen, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet, Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Xylometazoline and Cocaine for Nasal Vasoconstriction

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