Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:28 PM
Study NCT ID:
NCT00967694
Status:
COMPLETED
Last Update Posted:
2014-09-23
First Post:
2009-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Nitrous Oxide (N2O) on Intraocular Pressure in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ericbfox@yahoo.com', 'phone': '775-340-0219', 'title': 'Dr. Eric Fox', 'organization': 'University of Utah Department of Anesthesiology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 week', 'eventGroups': [{'id': 'EG000', 'title': 'Nitrous Oxide Administration', 'description': '20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.', 'otherNumAtRisk': 26, 'otherNumAffected': 6, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea/vomiting', 'notes': '1 participants experienced transient, self-limited, mild nausea/vomiting and chose to withdraw from the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphoria', 'notes': '5 participants experienced transient, self-limited, mild dysphoria and chose to withdraw from the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Intraocular Pressure During Nitrous Oxide Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitrous Oxide Administration', 'description': 'All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline (prior to nitrous oxide administration) and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore one study arm, with each individual serving as their control for baseline (before nitrous oxide administration) and then intervention values of IOP measurement (during nitrous oxide administration), and then washout values of IOP (after breathing room air).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '-0.81', 'upperLimit': '2.9'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000'], 'groupDescription': 'A linear mixed effects model was used to assess change in IOP over time using time-points as the primary independent variable with significance set at p \\< 0.05. Power calculations showed that 20 subjects would allow detection of a 2.8-mmHg difference in IOP between any two time-points with 80% power assuming a standard deviation of 3.5 mmHg for IOP and a correlation between two time- points of 0.25', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Before, during and after administration of nitrous oxide (45 minutes total)', 'unitOfMeasure': 'mmHg (difference in IOP)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nitrous Oxide Administration', 'description': 'All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '5 discontinued during N2O administration due to agitation ⁄ dysphoria, one due to nausea⁄vomiting.', 'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Nitrous Oxide Administration', 'description': 'All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.6', 'spread': '6.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'American Society of Anesthesiologists Physical Classification System (ASA) class', 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.307', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Scale Range 1 to 6 with one being better, 6 being worst.\n\nASA Physical Status 1 - A normal healthy patient ASA Physical Status 2 - A patient with mild systemic disease ASA Physical Status 3 - A patient with severe systemic disease ASA Physical Status 4 - A patient with severe systemic disease that is a constant threat to life ASA Physical Status 5 - A moribund patient who is not expected to survive without the operation ASA Physical Status 6 - A declared brain-dead patient whose organs are being removed for donor purposes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Mean Intraocular Pressure (IOP)', 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '2.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Mean Arterial Pressure', 'classes': [{'categories': [{'measurements': [{'value': '86.4', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Volunteers recruited via locally placed posters, research opportunities website and email servers. Power calculations estimated 20 subjects would be needed to detect a 2.8mmHg difference in IOP. 26 subjects began nitrous oxide administration, with 6 choosing to withdraw. Baseline analysis based on the 20 participants completing the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-15', 'studyFirstSubmitDate': '2009-08-27', 'resultsFirstSubmitDate': '2014-04-24', 'studyFirstSubmitQcDate': '2009-08-27', 'lastUpdatePostDateStruct': {'date': '2014-09-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-15', 'studyFirstPostDateStruct': {'date': '2009-08-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Intraocular Pressure During Nitrous Oxide Sedation', 'timeFrame': 'Before, during and after administration of nitrous oxide (45 minutes total)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Nitrous oxide'], 'conditions': ['Glaucoma', 'Sedation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn if breathing nitrous oxide (also known as "laughing gas") changes the pressure in a person\'s eyes. Some patients who need regular eye exams to measure their eye pressure often need to be put to sleep with medicine in order to complete the eye exam. Some of these medicines are known to cause changes in a person\'s eye pressure. Because of this, such medicines are avoided if the eye doctor needs to measure the patient\'s eye pressure. One medicine that is frequently used to put patients to sleep is nitrous oxide. No one really knows what effect nitrous oxide might have on a persons\' eye pressure. The investigators are interested to see if nitrous oxide causes an increase, decrease, or no change in eye pressure. The investigators also want to investigate if there is a difference in the effects of nitrous oxide on eye pressure between males and females. Understanding these effects of nitrous oxide is important because during such eye exams, the eye doctor uses the pressure measurements to make important decisions about treatment and surgery options for the patient.\n\nThe investigators hypothesize that the use of inhaled nitrous oxide (N2O) will result in a decrease in IOP in healthy volunteers.\n\nThe investigators aim to determine the magnitude and duration of change, if any, in IOP caused by inhalation of N2O, and to assess if the gender of the patient has a role in this effect.', 'detailedDescription': 'An initial pre-anesthetic evaluation and physical examination will be performed by an attending anesthesiologist, and an eye exam will be performed by an attending ophthalmologist to determine suitability for inclusion according to the above criteria. Ideally the eye exam will take place immediately prior to conduction of the study. However, logistical restraints may require that the eye exam take place at a separate time/date prior to conduction of the study. IOPs will be measured by the attending ophthalmologist (B.E.) who will be blinded to the actual readings of the Tonopen by means of a small screen, and a single trained observer (E.F.) will record observations from the Tonopen. The nitrous oxide sedation will be managed by the attending anesthesiologist (K.L.). All patients will be monitored throughout using standardized monitoring (continuous EKG, non-invasive BP, and continuous pulse oximetry).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-40\n* American Society of Anesthesiologists Physical Classification System (ASA) Status 1-2\n* Nil per os (NPO) prior to study (2 hrs clear liquids, 4 hrs milk, 6 hrs light food, 8 hrs heavy/greasy food)\n\nExclusion Criteria:\n\n* Lack of volunteer consent\n* Pregnancy\n* History of features suggestive of a difficult airway on pre-anesthetic evaluation and physical examination\n* Active gastroesophageal reflux disease\n* Active obstructive sleep apnea\n* History of recent trauma\n* History of pneumothorax or lung cyst\n* History of Vitamin B12 deficiency\n* History of recent middle ear surgery (\\<3months)\n* Current or recent (\\<3 weeks) respiratory tract infection\n* Any acute illness or exacerbation of chronic illness such as asthma, chronic lung disease etc.\n* Any history of cardiac ischemia (angina), myocardial infarction, or cardiac dysrhythmia.\n* Myopia greater than -3 spherical equivalents or hyperopia greater than +3 spherical equivalents\n* History of eye surgery of any sort, including refractive surgery, cataracts, and vitrectomy\n* History of any ocular disease or infection'}, 'identificationModule': {'nctId': 'NCT00967694', 'briefTitle': 'Effect of Nitrous Oxide (N2O) on Intraocular Pressure in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Effect of N2O on Intraocular Pressure in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'IRB00005402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitrous oxide administration', 'description': 'All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.', 'interventionNames': ['Drug: Nitrous oxide']}], 'interventions': [{'name': 'Nitrous oxide', 'type': 'DRUG', 'otherNames': ['N2O'], 'description': 'Nitrous oxide sedation by inhalation', 'armGroupLabels': ['Nitrous oxide administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Kirk Lalwani, MD,FRCA,MCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert L. Bacon Medical Foundation', 'class': 'UNKNOWN'}, {'name': 'Research to Prevent Blindness', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Anesthesiology and Pediatrics', 'investigatorFullName': 'Kirk Lalwani', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}