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临床试验/NCT06443255
NCT06443255招募中3 期

Comparison of Cocaine, Lidocaine/Xylometazoline and Saline for Intranasal Analgesia - A Blinded Triple Crossover Study

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
招募中
入组人数
12
试验地点
1
主要终点
Pain regarding the procedure

研究概览

简要总结

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. The procedure can be deemed necessary due to the nature of the surgical procedure or considerations in regard to the patient's comorbidities. For a certain group of patients with expected difficult airways, the procedure is done whilst they are awake and aided by fiberoptics.

For these awake patients, extra precautions must be taken to ensure the procedure is conducted with minimal pain and discomfort. The pain and discomfort arises from the mechanical manipulation of the nasal mucosa and can be alleviated in part by means of topical analgesia as well as through decongestion, providing more space within the nasal cavity. For these purposes, several drugs in varying combinations and dosages are used, but no single drug choice is universally recommended.

Cocaine is one of these appropriate drugs. It is a magistral formula used especially due to its unique combination of both vasoconstrictive and analgesic properties. Concerns have though been raised regarding cocaine's potential toxicity and alternative medications are continuously sought after.

A combination of lidocaine and xylometazoline can also be used for preparation of the nose prior to awake nasal fiberoptic intubation. Lidocaine contributes with its analgesic effect whilst xylometazoline functions as the vasoconstrictor.

The investigators wish to compare the analgesic effects of cocaine and lidocaine/phenylephrine to each other and saline when subjectively scored on a visual analogue scale of 0-100 mm immediately after simulated awake nasal intubation on healthy volunteers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Proficient in spoken and written Danish
  • Healthy volunteers (no active diagnoses)
  • Negative hCG (human chorionic gonadotropin) urine stix for women of childbearing potential

排除标准

  • Known nasal malformation
  • Known coagulopathy
  • Current antithrombotic treatment
  • Self-reported epistaxis occurring more than once a month
  • Symptoms of a common cold within the past week
  • Hypersensitivity to local anaesthetics of amide type or any of the excipients
  • Hypertension
  • Narrow-angle glaucoma

研究组 & 干预措施

Cocaine

Active Comparator

2 mL 4% cocaine hydrochloride

干预措施: Cociane hydrochloride 4% (Drug)

Xylometazoline and lidocaine

Active Comparator

1.5 mL of 4% lidocaine and 0.5 mL 0.1% xylometazoline

干预措施: Lidocaine 4% (Drug)

Xylometazoline and lidocaine

Active Comparator

1.5 mL of 4% lidocaine and 0.5 mL 0.1% xylometazoline

干预措施: Xylometazoline 0.1% (Drug)

Saline

Placebo Comparator

2 ml of 0,9% saline solution

干预措施: Saline 0.9% (Drug)

结局指标

主要结局

Pain regarding the procedure

时间窗: Immediately following the procedure of 10 cm insertion of a 6.0 nasal endotracheal tube

Self reported pain on a visual analogue scale of 0-100 mm

次要结局

  • Pain regarding the procedure(One minute after the procedure of insertion of a 6.0 nasal endotracheal tube)
  • Volume(5 minutes before drug administration and 1, 3, 5, 7 and 9 minutes after drug administration)
  • Blood pressure(5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration)
  • Fiberoptic endoscopy(Fiberoptic endoscopy performed 10 minutes before drug administraion and 10 minutes after drug administration)
  • Heart rate(5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration)
  • Drug test detection(15 minutes before drug administration and 1, 2 and 3 hours after drug administration)
  • Patient-centred questions(15 minutes after drug administration)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mo Haslund Larsen

Principal investigator

Rigshospitalet, Denmark

研究点 (1)

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