Drug Test Detection of Cocaine for Nasal Intubation

NCT05334056 | Completed

• 3 other identifiers: 505106172021-000709-26H-21028055
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine whether it is possible to detect traces above national cut-offs of either cocaine's main metabolite benzoylecgonine in saliva or cocaine in blood 24 hours after administering 2 ml of 40 mg/ml cocaine-saline to the nasal mucosa. The investigators hypothesize that the level of cocaine's main metabolite bezoylecgonine in saliva after cocaine administered for anesthetic purposes will be below detection limits after 24 hours.

Conditions

Cocaine Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Saliva analysis

  Analysis of cocaine's main metabolite benzoylecgonine in saliva measured in nanograms per milliliter

  24 hours after cocaine administration

Secondary Outcomes (1)

• Whole blood toxicology

  1 hour and 24 hours after cocaine administration

Interventions

Cocaine Nasal DRUG

2 ml of 4% cocaine given as a nasal spray immediately prior to nasal intubation

Also known as: Cocaine 4%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients schedualed to undergo surgery at Rigshospitalet with the use of nasal intubation.

You may qualify if:

• Age ≥ 18 years
• Scheduled for nasal intubation
• Proficient in spoken and written Danish
• Negative baseline cocaine saliva test

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and whole blood samples. Saliva samples will be analyzed immediately following collection and disposed as biological waste upon securing the analysis result. Whole blood samples will be stored until inclusion is complete and will hereafter be analyzed in one batch. Immediately following analysis the samples will be discarded as biological waste.

Study Officials

• Mo Haslund Larsen, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: March 22, 2023
• Primary Completion: May 27, 2023
• Study Completion: May 27, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)