Comparison of xylometazoline vs. cocaine for prevention of nose bleeds upon intubatio

Phase 1

• Conditions: Epistaxis upon nasal intubation; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2021-000691-11-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-05
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

•Age = 18 years
•Scheduled for nasal intubation
•Proficient in spoken and written Danish

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

•Intubation to be done on awake patient
•Pregnancy in fertile women (Women under the age of 50 must produce a negative hCG urine stix to participate)
•Known symptomatic coronary disease (As declared by patient or noted in the patient's file)
•Uncontrolled hypertension (As declared by patient or noted in the patient's file + Not taking antihypertension drugs)
•Closed-angle glaucoma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): Evaluation of epistaxis immediately following nasal intubation measured on a predefined score of 1-4.;Timepoint(s) of evaluation of this end point: Immediately following intubation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Qualitative binary result of saliva analysis testing for cocaine (in cocaine group only)<br><br>and<br><br>Quantitative result of whole blood toxicology testing for cocaine (in cocaine group only);Timepoint(s) of evaluation of this end point: 1) On morning of operation<br>2) 60 minutes after cocaine administration<br>3) 24 hours after cocaine administration