Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT01199458
Status:
COMPLETED
Last Update Posted:
2016-11-09
First Post:
2010-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of an Opioid on the Lower Esophageal Sphincter During Anesthesia Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015760', 'term': 'Alfentanil'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-08', 'studyFirstSubmitDate': '2010-09-08', 'studyFirstSubmitQcDate': '2010-09-10', 'lastUpdatePostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter.', 'timeFrame': '1 min after the application of the induction agent (propofol)', 'description': 'Pressure variations in the lower esophageal sphincter will be measured continuously during the whole study. Registrations will be saved in the computer-software. Predetermined time points will be marked on the registrations for later evaluation.'}], 'secondaryOutcomes': [{'measure': 'Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter.', 'timeFrame': 'during cricoidpressure application (continues for 15 sec)', 'description': 'Pressure variations in the lower esophageal sphincter will be measured continuously during the whole study. Registrations will be saved in the computer-software. Predetermined time points will be marked on the registrations for later evaluation.'}, {'measure': 'Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter.', 'timeFrame': '1min after the opioid/placebo injection', 'description': 'Pressure variations in the lower esophageal sphincter will be measured continuously during the whole study. Registrations will be saved in the computer-software. Predetermined time points will be marked on the registrations for later evaluation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lower Esophageal Sphincter', 'Barrier pressure'], 'conditions': ['Lower Esophageal Sphincter']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of adding an opioid (alfentanil) during anesthesia induction with respect to the barrierpressure in the esophagogastric junction.\n\nThe secondary aim was to investigate whether the effect of cricoid pressure influences the barrierpressure.', 'detailedDescription': 'During anesthesia induction and tracheal intubation one major concern is to avoid passive regurgitation of gastric content and aspiration.\n\nThe lower esophageal sphincter is a muscle located at the distal end of the esophagus. It plays an important role in creating a barrier between the stomach and the esophagus. The term "barrierpressure" is defined as the pressure difference between the lower esophageal sphincter pressure and the pressure in the stomach (intragastric pressure).\n\nThere are studies showing that opioids given iv/im, in the vein or in the muscle, may decrease the pressure in the lower esophageal sphincter and hereby increase the risk of aspiration.\n\nNevertheless,other studies shows that opioids are still frequently given to patients during anesthesia induction. This is done in order to prevent the cardiovascular response to (the painful) intubation which can often be seen as an equally high risk for the patient as the risk of aspiration.\n\nIn light of the above description, the investigators are planning a study in volunteers with the primary aim of investigating the effects of an opioid (alfentanil) on the pressures in the lower esophageal sphincter.\n\nAnother safety measure taken during anesthesia induction is the so called "cricoid pressure". This is based on the theory that passive regurgitation of gastric content may be prevented by occluding the esophagus by pressing on the cricoid cartilage. However, there are studies indicating that the application of cricoid pressure also may decrease the tonus of the lower esophageal sphincter.\n\nThe secondary aim of the study is to investigate the effect of cricoid pressure application on the pressure in the lower esophageal sphincter.\n\nMeasurements are being done using high-resolution solid-state manometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteer 18-40 years old\n* Informed,signed and dated consent\n\nExclusion Criteria:\n\n* Pharyngoesophageal dysfunction\n* Gastro/intestinal-,cardiovascular-,lung- or neurologic disease\n* Ongoing medication\n* Allergy to alfentanil, propofol, soya or peanuts\n* Pregnancy or breast-feeding\n* BMI\\>30\n* Participation in other clinical trial -ongoing or during last 30 days.'}, 'identificationModule': {'nctId': 'NCT01199458', 'briefTitle': 'The Effect of an Opioid on the Lower Esophageal Sphincter During Anesthesia Induction', 'organization': {'class': 'OTHER', 'fullName': 'Region Örebro County'}, 'officialTitle': 'The Effect of Alfentanil on the Lower Esophageal Sphincter During Anesthesia Induction - a Study in Volunteers', 'orgStudyIdInfo': {'id': 'EudraCT nr: 2010-020697-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'opioid', 'description': 'Preoxygenation for 5 min. Injection of opioid (alfentanil 20 mikrogr/kg iv) after 2 min:Injection of induction drug(propofol 2-2.5mg/kg) after anesthesia induction: Application of cricoid pressure for 15 sec.', 'interventionNames': ['Drug: alfentanil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Preoxygenation for 5 min. Injection of saline iv. after 2 min:Injection of induction drug(propofol 2-2.5mg/kg) after anesthesia induction: Application of cricoid pressure for 15 sec.', 'interventionNames': ['Drug: saline']}], 'interventions': [{'name': 'alfentanil', 'type': 'DRUG', 'otherNames': ['alfentanil = rapifen'], 'description': '20 mikrogr/kg', 'armGroupLabels': ['opioid']}, {'name': 'saline', 'type': 'DRUG', 'description': 'The amount of saline will be equal the amount (in ml) of the study-drug (alfentanil)in order to keep it blinded.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21740', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Örebro University', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'overallOfficials': [{'name': 'Magnus Wattwil, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesia and Intensive Care, Örebro University Hospital, Örebro,Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Original data can be available by contacting the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Örebro County', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}