Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA | NCT04305158

Studies
Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA

NCT04305158

Sponsor

University of Arkansas

Status

Completed

Last Update Posted

Apr 11, 2024Actual

Enrollment

200Actual

Phase

Early Phase 1

Conditions

Nitrous Oxide

Interventions

Nitrous Oxide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 28, 2022Actual

Primary Completion Date

Aug 10, 2023Actual

Completion Date

Aug 10, 2023Actual

First Submitted Date

Mar 9, 2020

First Submission Date that Met QC Criteria

Mar 9, 2020

First Posted Date

Mar 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2024

Last Update Posted Date

Apr 11, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Colon cancer is the second most common cancer in men and the third most common cancer in women worldwide. The clinical objectives of administering sedation for GI endoscopy are to relieve patient anxiety and discomfort and to improve the outcome of the examination. Use of N2O could potentially provide an alternate safe and cheap option for patients who do not prefer IV sedation for colonoscopy

Detailed Description

Patients who are considered low risk for anesthesia administration (ASA class \

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nitrous Oxide	Experimental	Patient receiving Nitrous Oxide are evaluated for success of the procedure	Drug: Nitrous Oxide
IV Sedation group	Active Comparator	In this group a combination of Midazolam and Fentanyl is used per endoscopic discretion	Drug: Nitrous Oxide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nitrous Oxide	Drug	Patient receiving nitrous oxide are evaluated for success of the procedure	IV Sedation group Nitrous Oxide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cecal intubation rates and time of the procedure - total time and recovery	Time required to complete the procedure and reach end of the colon	1 to 30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women, more than 18 years old Scheduled for a colonoscopy at the Endoscopy unit

Exclusion Criteria:

High ASA risk (IV/ >)
History of chronic pain
Allergy to N2O or opioid or BDZ
No consent
Recent head injury with impairment of consciousness or Intracranial / Middle Ear surgery within the previous 6 months with or without residual deficits.
Pneumothorax, air embolism
Decompression sickness or within 48 hours of an underwater dive
Severe emphysema with bullae
Gross abdominal distension with suspicion for bowel obstruction
Intoxication
Maxillofacial injuries (where patient unable to administer the drug using a mouthpiece/mask, or there is the risk of causing further damage to facial wounds and there may also be a significant risk of blood inhalation)
Patients with chronic pulmonary disease for whom an inspired oxygen concentration of more than 28% oxygen might be dangerous
Patients on Methotrexate
Where patients need assistance to hold the mask or mouthpiece.
Retinal surgery within the last three months
Any patient who does not otherwise clinically qualify for standard sedation methods (i.e., those who require general anesthesia)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009589	Nitrogen Oxides
D005740	Gases
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds