Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults

NCT02410707 | Completed Results DMC

• 1 other identifier: HN4641
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to describe the safety and efficacy of nitrous oxide administration for pain and anxiety before propofol in patients requiring any procedure under sedation in the Emergency Department. Procedural sedation is the use of sedative, analgesic, and/or dissociative agents to relieve anxiety and pain associated with diagnostic and therapeutic procedures. Propofol is commonly used and is a sedative and amnestic, but provides no analgesia. Short acting opioids may be used for pain relief, but come with the risk of respiratory depression. An optimum analgesic to relieve pain in patients who need procedural sedation should be short acting, easy to administer and safe. Nitrous oxide may be a suitable agent, but literature supporting or rejecting its use in adults is lacking. This study aims to fill this gap. Adult patients capable of consenting, coming to the Emergency Department with painful condition requiring procedural sedation are the targeted population. Eligible patients who consent to the study will receive Nitrous Oxide gas delivered through a hand held mask before they receive propofol for the procedure. Information regarding their vitals, pain scores and medical condition will also be collected.

Conditions

Joint Dislocation; Perianal Abscess; Abscess

Keywords

procedural sedation; procedural pain; procedural anxiolysis

Outcome Measures

Primary Outcomes (1)

• Total Number of Respiratory Depression Events

  End tidal CO2 and SpO2 measured every 20 milliseconds seconds captured by a monitoring device. Events of respiratory depression are defined as peripheral SaO2 below 92%, ETCO2 level above 50, a rise or decrease of 10% above or below baseline, and/or the loss of the ETCO2 waveform for more than 15 seconds

  day 1

Secondary Outcomes (7)

• Total Number of Airway Repositioning Events

  day 1

• Total Number of Events Requiring Additional Oxygen

  day 1

• Total Number of Positive Pressure Ventilation Events

  day 1

• Total Number of Endotracheal Intubation Events

  day 1

• Total Number of Physical Stimulation Events

  day 1

Study Arms (1)

Nitrous Oxide Arm

EXPERIMENTAL

Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.

Drug: Nitrous Oxide arm; Drug: Propofol; Drug: Oxygen

Interventions

Nitrous Oxide arm DRUG

Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.

Also known as: Nitrous Oxide, Sedera Gas Mixer, Propofol Sedation, Procedural Sedation

Nitrous Oxide Arm

Propofol DRUG

The loading dose of propofol will be administered immediately after nitrous oxide discontinuation. All sedations in this trial will use propofol 1.0 mg/Kg initial dose, with 0.5 mg/Kg doses titrated to deep sedation. Once the patient is deeply sedated, the procedure will begin.

Also known as: Diprivan

Nitrous Oxide Arm

Oxygen DRUG

If pulse oximetry declines to less than 92%, subject will be placed on nasal cannula with administration of 2 liter flow of oxygen and titrated in increments of 1 L flow to maintain pulse oximetry greater than 92%

Also known as: O2

Nitrous Oxide Arm

Eligibility Criteria

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

You may qualify if:

• Spontaneous respirations
• years of age and older
• American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2, who will be receiving sedation for an Emergency Department procedure.
• Ability to provide informed consent.

You may not qualify if:

• Comorbidities that affect ventilation, perfusion, or metabolism
• Intubated
• Cardiopulmonary instability
• Major trauma
• Sepsis
• American Society of Anesthesiologists (ASA) class 3, 4, and 5.
• Inability to provide informed consent
• Nursing home residents
• Age less than 18 years
• Non English speaking
• Pregnant women
• Under police custody

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Joint Dislocations; Abscess; Pain, Procedural

Interventions

Nitrous Oxide; Propofol; Oxygen

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chalcogens; Elements

Results Point of Contact

• Title: Joseph Herres, DO, Director of Research
• Organization: Einstein Healthcare Network

herresjo@einstein.edu

215-456-6666

Study Officials

• Joseph Herres, DO

  Albert Einstein Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: April 8, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 8, 2020
• Results First Posted: April 8, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)