Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 10:46 PM
Study NCT ID:
NCT01277861
Status:
COMPLETED
Last Update Posted:
2013-03-15
First Post:
2010-11-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Airway Responses During Desflurane Anesthesia Via a Laryngeal Mask Airway: Effects of Fentanyl Pretreatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'girish.joshi@utsouthwestern.edu', 'phone': '214-590-7259', 'title': 'Girish P. Joshi, MD', 'organization': 'University of Texas Southwestern Medical Center at Dallas'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Patients were followed for up to 24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'FENTANYL', 'description': 'FENTANYL', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SALINE', 'description': 'SALINE', 'otherNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl Pretreatment Group', 'description': 'Fentanyl 1 µg/kg (constituted to 10 ml with saline) prior to induction of anesthesia.'}, {'id': 'OG001', 'title': 'Saline Pretreatment Group', 'description': 'Saline 10 ml prior to induction of anesthesia.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Induction of Anesthesia', 'description': 'The data provided below include participants who moved (includes all grades of movement ie, mild, moderate and severe).', 'unitOfMeasure': 'Participants, number', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Apnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl Pretreatment Group'}, {'id': 'OG001', 'title': 'Saline Pretreatment Group'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Induction of Anesthesia', 'description': 'Apnea defined as no breathing for at least 30 s.', 'unitOfMeasure': 'Participants, number', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Coughing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl Pretreatment Group', 'description': 'Fentanyl 1 µg/kg (constituted to 10 ml with saline) prior to induction of anesthesia.'}, {'id': 'OG001', 'title': 'Saline Pretreatment Group', 'description': 'Saline 10 ml prior to induction of anesthesia.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Intraoperative period', 'description': 'Data include patients who coughed irrespective of the degree of coughing.', 'unitOfMeasure': 'Participants, number', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FENTANYL', 'description': 'FENTANYL'}, {'id': 'FG001', 'title': 'SALINE', 'description': 'SALINE'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patients were recruited for the study in the preoperative period.', 'preAssignmentDetails': 'Participants were included based on inclusion/exclusion criteria. Participants were excluded if muscle relaxation was necessary for the surgery.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FENTANYL', 'description': 'FENTANYL'}, {'id': 'BG001', 'title': 'SALINE', 'description': 'SALINE'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '26.8', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '26.8', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index is calculated from height and weight of the patient.', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-14', 'studyFirstSubmitDate': '2010-11-03', 'resultsFirstSubmitDate': '2012-02-16', 'studyFirstSubmitQcDate': '2011-01-13', 'lastUpdatePostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-14', 'studyFirstPostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Movement', 'timeFrame': 'Induction of Anesthesia', 'description': 'The data provided below include participants who moved (includes all grades of movement ie, mild, moderate and severe).'}], 'secondaryOutcomes': [{'measure': 'Apnea', 'timeFrame': 'Induction of Anesthesia', 'description': 'Apnea defined as no breathing for at least 30 s.'}, {'measure': 'Coughing', 'timeFrame': 'Intraoperative period', 'description': 'Data include patients who coughed irrespective of the degree of coughing.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Desflurane, Fentanyl, Airway responses'], 'conditions': ['Administration Site Reaction']}, 'descriptionModule': {'briefSummary': 'The investigators plan to test the hypothesis that pretreatment with fentanyl prior to induction of anesthesia would result in reduce the incidence of movements and airway responses to desflurane in patients breathing spontaneously through a laryngeal mask airway (LMA). The primary aim of this study is to assess the effect of fentanyl pretreatment on the incidence of movement during induction of anesthesia. Secondary aim of the study is to evaluate the effects of titration of fentanyl according to the respiratory rate on the incidence of intraoperative respiratory events such as coughing, breath holding and laryngospasm.', 'detailedDescription': 'After obtaining approval from the institutional review board and informed consent, 100 patients, 18-64 years of age, scheduled for elective superficial and peripheral surgery of less than 2 h duration would be enrolled in this prospective, randomized, double-blind, placebo-controlled study. Patients will be randomly assigned to one of two anesthetic techniques according to a computer-generated random numbers table. Patients will receive either fentanyl or saline prior to induction of anesthesia, while the rest of the anesthetic and analgesic technique will be standardized for all patients.\n\nExclusion criteria will include obesity (body mass index \\>30), pregnancy, history of gastroesophageal reflux, hiatal hernia, significant cardiovascular, pulmonary (e.g., reactive airway disease), hepatic, renal, neurologic, metabolic, and endocrine disease as well as history of alcohol and drug abuse as well as those requiring tracheal intubation.\n\nAfter premedication with midazolam 2 mg, patients will be transferred to the operating room. On arrival in the operating room standard monitors and the BIS (BiSpectral Index)monitor will be applied. Patients will then be preoxygenated for 2-3 minutes with 100% oxygen, which will be followed by administration of either fentanyl 1 µg/kg (made up to 10 ml saline) or 10 ml saline (prepared by a person not involved in the study). Induction of anesthesia will be performed 2-3 minutes after administration of the study drug with propofol 2.0 - 2.5 mg/kg after lidocaine 2% 20-30 mg. After loss of eyelash reflex an appropriate size LMA will be placed. If the patients become apneic, manual ventilation will be performed with oxygen/nitrous oxide and desflurane, 3% dialed concentration initially and then titrated to maintain the BIS value of 50-60.\n\nAnesthesia will be maintained with desflurane titrated to achieve a BIS value of 50-60, along with 50% nitrous oxide and oxygen. Once spontaneous breathing resumes, fentanyl 25-50 µg will be administered to achieve a respiratory rate of 10-15 breaths/minute. Additional propofol/fentanyl will be administered, if deemed necessary by the attending anesthesiologist. All patients will receive dexamethasone 4 mg, IV after induction of anesthesia and ondansetron 4 mg 20-30 minutes prior to the end of surgery. Desflurane will be discontinued after closure of the surgical wound.\n\nA blinded observer will record patient demographics (age, weight, height) and history of smoking from preoperative evaluation. Data collected during the intraoperative period will include need for manual ventilation and duration of manual ventilation, duration of anesthesia, total doses of propofol and fentanyl, and time from discontinuation of desflurane until patient first follows verbal command as well as heart rate (HR), mean arterial blood pressure (MAP), end-tidal carbon dioxide, oxygen saturation, and end-tidal gas concentration will be recorded every 15 minutes.\n\nData collected in the postoperative period will include verbal rating score (0 to 10) will be used to assess pain, nausea, and vomiting in the recovery room every 15 minutes for one hour as well as the need for rescue medications will also be recorded.\n\nPatients will also be contacted approximately 24 hours after surgery to evaluate their post operative course including occurrence of any adverse events. The patient will remain in the study for approximately 24 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-64 years of age\n* Subjects scheduled for elective superficial and peripheral surgery of less than 2 h duration (e.g., hernia surgery, breast surgery, upper or lower limb surgery, superficial abdominal/chest wall surgery \\[i.e., lipoma\\], minor gynecological procedures \\[i.e., hysteroscopy\\])\n\nExclusion Criteria:\n\n* obesity (body mass index \\>30)\n* pregnancy\n* history of gastroesophageal reflux, hiatal hernia, significant cardiovascular, pulmonary (e.g., reactive airway disease), hepatic, renal, neurologic, metabolic, and endocrine disease\n* history of alcohol and drug abuse\n* requiring tracheal intubation.'}, 'identificationModule': {'nctId': 'NCT01277861', 'briefTitle': 'Airway Responses During Desflurane Anesthesia Via a Laryngeal Mask Airway: Effects of Fentanyl Pretreatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Airway Responses During Desflurane Anesthesia Via a Laryngeal Mask Airway: Effects of Fentanyl Pretreatment', 'orgStudyIdInfo': {'id': '092010-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FENTANYL', 'description': 'FENTANYL', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SALINE', 'description': 'SALINE', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'description': 'FENTANYL PRETREATMENT DURING INDUCTION OF ANESTHESIA', 'armGroupLabels': ['FENTANYL', 'SALINE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Ut Southwestern Medical Center At Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Girish P Joshi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center, Dallas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Girish P Joshi, MD', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}