Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-29 @ 1:38 PM
Study NCT ID:
NCT01371968
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2011-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Dose of Alfentanil for Removal of Supreme Laryngeal Mask Airway During Emergence From Desflurane Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015760', 'term': 'Alfentanil'}], 'ancestors': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-25', 'studyFirstSubmitDate': '2011-05-04', 'studyFirstSubmitQcDate': '2011-06-10', 'lastUpdatePostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimal dose of alfentanil for successful LMA removal in spontaneously breathing anaesthetized adults', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Number of patient with airway complication', 'timeFrame': 'after administration of alfentanil and within 1 min of LMA removal'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Alfentanil', 'optimal dose', 'laryngeal mask airway'], 'conditions': ['Airway Response']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the optimal dose of alfentanil in suppressing the airway reflexes during supreme LMA removal in anaesthetized adult.', 'detailedDescription': 'The removal of LMA may be associated with coughing, biting, agitation and airway complication such as laryngospasm. Thus it is advisable to remove the LMA when the patient is breathing spontaneously and when the airway reflexes are still depressed. A number of techniques have been used to prevent this adverse emergence phenomenon, such as removing the tube while the patient is in deep plane of anaesthesia or administration of local anaesthetic and intravenous opioids\n\nThe administration of intravenous opioids before emergence may be useful for preventing cough, agitation and hemodynamic response. Alfentanyl is proven to suppress cough and agitation during the endotracheal tube emergence. However, its use in suppressing cough in LMA patient has not been evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA I and II patients\n2. Age 18 to 49 years old\n3. Minor elective day care surgery (\\> 20 minute and less than 2 hours) which require local anaesthetic infiltration and does not require use of long acting opioids.\n\nExclusion Criteria:\n\n1. Potential difficult airway\n2. Reactive airway disease or sign and symptoms of upper respiratory tract infection.\n3. History of cardiac, pulmonary and renal diseases\n4. Body Mass Index \\> 30 kgm2.\n5. Risk of aspiration.\n6. Poor dentition with high risk of damage.\n7. Patient refusal.'}, 'identificationModule': {'nctId': 'NCT01371968', 'briefTitle': 'Optimal Dose of Alfentanil for Removal of Supreme Laryngeal Mask Airway During Emergence From Desflurane Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Optimal Dose of Alfentanil for Removal of Supreme Laryngeal Mask Airway During Emergence From Desflurane Anaesthesia', 'orgStudyIdInfo': {'id': 'Alfentanil LMA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'alfentanil', 'description': 'patient will received a dose of alfentanil in which the dose of alfentanil is determined by response of previously tested patient using Dixon up and down methods', 'interventionNames': ['Drug: alfentanil']}], 'interventions': [{'name': 'alfentanil', 'type': 'DRUG', 'otherNames': ['Rapifen'], 'description': 'Alfentanil is administered intravenously at the end of surgery.', 'armGroupLabels': ['alfentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'overallOfficials': [{'name': 'Lee Chew Kiok, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiogy, UMMC.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'collaborators': [{'name': 'Malaysian Society of Anaesthesiologists', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University of Malaya', 'investigatorFullName': 'Lee Chew Kiok', 'investigatorAffiliation': 'University of Malaya'}}}}