Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT04305158
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2020-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009609', 'term': 'Nitrous Oxide'}], 'ancestors': [{'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2020-03-09', 'studyFirstSubmitQcDate': '2020-03-09', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cecal intubation rates and time of the procedure - total time and recovery', 'timeFrame': '1 to 30 minutes', 'description': 'Time required to complete the procedure and reach end of the colon'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moderate sedation', 'Nitrous oxide', 'Screen colonoscopy'], 'conditions': ['Nitrous Oxide']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'Patients who are considered low risk for anesthesia administration (ASA class \\<IV) receive moderate sedation with a combination of intravenous benzodiazepine and opioid medication. an alternative method of providing analgesia with "on-demand" inhalation of nitrous oxide (hereafter referred to as N2O) combined with oxygen has been postulated. Nitrous Oxide has been used for analgesia in various procedures including childbirth, general anesthesia, pediatric dentistry, bone marrow aspiration, fracture reductions, and minor surgical procedures (surgical dressings, pulmonary endoscopy, an abscess . It could potentially reduce overall costs for the procedure, in addition to providing a quicker recovery, turn over'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMen and women, more than 18 years old Scheduled for a colonoscopy at the Endoscopy unit\n\nExclusion Criteria:\n\n* High ASA risk (IV/ \\>)\n* History of chronic pain\n* Allergy to N2O or opioid or BDZ\n* No consent\n* Recent head injury with impairment of consciousness or Intracranial / Middle Ear surgery within the previous 6 months with or without residual deficits.\n* Pneumothorax, air embolism\n* Decompression sickness or within 48 hours of an underwater dive\n* Severe emphysema with bullae\n* Gross abdominal distension with suspicion for bowel obstruction\n* Intoxication\n* 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)\n* Patients with chronic pulmonary disease for whom an inspired oxygen concentration of more than 28% oxygen might be dangerous\n* Patients on Methotrexate\n* Where patients need assistance to hold the mask or mouthpiece.\n* Retinal surgery within the last three months\n* Any patient who does not otherwise clinically qualify for standard sedation methods (i.e., those who require general anesthesia)'}, 'identificationModule': {'nctId': 'NCT04305158', 'briefTitle': 'Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA', 'orgStudyIdInfo': {'id': '239435'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitrous Oxide', 'description': 'Patient receiving Nitrous Oxide are evaluated for success of the procedure', 'interventionNames': ['Drug: Nitrous Oxide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV Sedation group', 'description': 'In this group a combination of Midazolam and Fentanyl is used per endoscopic discretion', 'interventionNames': ['Drug: Nitrous Oxide']}], 'interventions': [{'name': 'Nitrous Oxide', 'type': 'DRUG', 'description': 'Patient receiving nitrous oxide are evaluated for success of the procedure', 'armGroupLabels': ['IV Sedation group', 'Nitrous Oxide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Stephan Dehmel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}