Nitrous Oxide Vasodilation Healthy Adult Volunteers

Peripheral Vasodilation in Healthy Adult Volunteers Receiving 50% Nitrous Oxide

Nitrous oxide (N2O) is a gas that is normally used to take away pain and anxiety during painful medical procedures. However, one of its effects is to also make veins appear larger and more visible. This is useful when there is a patient who needs to have an intravenous (IV) needle put in their skin to give them medicine or fluids, but may have veins that are very hard to see or feel. The mechanism of this observed effect is not entirely clear. The purpose of this study is to use an ultrasound to directly measure whether there is an actual change size of veins or change in blood flow in healthy adult volunteers when you give them 50% nitrous oxide, and see whether or not this change in size, or change in flow, is what causes the changes in visibility or palpability of the vein.

Study Overview

• Status: Terminated
• Conditions: Peripheral Vein Vasodilation
• Intervention / Treatment: Drug: 50% Nitrous oxide

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • NewYork Presbyterian Morgan Stanley Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adult volunteers.
• 19 years or older (inclusive)
• English speaking.

Exclusion Criteria:

• ASA class III or greater;
• History of, or suspected, difficult airway based on physical exam, facial dysmorphism or syndrome
• Any condition in which air may be trapped in a body cavity. These include, but are not limited to:

Pneumothorax or chest injury, concurrent acute asthma exacerbation, middle ear occlusion, intestinal obstruction, ileus, or abdominal distension, sinusitis or maxillofacial injuries with potential for trapped gas, recent intraocular surgery or penetrating globe injury, air embolus, severe bullous emphysema (consider in patients with cystic fibrosis), history of craniotomy in previous three weeks

• Pregnancy (1st and 2nd trimester)
• Increased intracranial pressure, impaired level of consciousness, or head injury
• Known Vitamin B12 deficiency
• Known MTHFR Deficiency (Inborn error of metabolism)
• History of bleomycin administration (note that the oxygen component of N2O administration is what interacts with bleomycin to cause pulmonary toxicity)
• Intoxication with alcohol or other drugs
• Any condition in which patient may be catecholamine-depleted (e.g. septic shock)
• Recent history of altered mental status
• Pulmonary hypertension
• Congestive heart failure.
• Trainees, including students, residents, and fellows, working in the pediatric emergency department.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50% Nitrous oxide	Drug: 50% Nitrous oxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diameter of peripheral vein (mm)	15-30 minutes at time of enrolment

Collaborators and Investigators

• Sponsor: Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: February 1, 2013
• First Submitted That Met QC Criteria: February 4, 2013
• First Posted (Estimate): February 6, 2013

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: AAAK2807