Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:00 AM
Study NCT ID:
NCT07480304
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-18
First Post:
2026-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate Effect of Nebulized Dexmedetomedine Upon Blunting Autonomic Response of Laeyngoscopy and Intubation in Patients Undergoing Elective Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-01', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'heart rate will be recorded at 0,1,5,10 min after laryngoscopy and intubation', 'timeFrame': 'Heart rate will be monitired at base line,0min,1min,5min,10min after intervention'}, {'measure': 'SBP,DBP,MAP. measurement will be required at o ,1,5,10 min after laryngoscopy and intubation.', 'timeFrame': 'SBP,DBP,MAP, will be recorded at 0,1,5,10 min after laryngoscopy and intubation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Evaluate Effect of Nebulized Dexmedetomedine Upon Blunting Autonomic Response of Laryngoscopy and Intubation in Patients Undergoing Elective Intubation']}, 'descriptionModule': {'briefSummary': 'Laryngoscopy and intubation are painful stimuli ,that results in adverse physiological outcomes,like tachycrdia ,hypertension,arrythmiaa,pulmonary edema.\n\nThe main objective of study is to blunt the autonomic response of laryngoscopy and intubation.\n\nTitle of the study :To evaluate the effect of dexmedetimedine nebulization upon blunting autonomic response of laryngoscopy and intubation in patients undergoing elective intubation.\n\nIt is randomized control trial,sample size was calculated by using openEpi sample size calculator By using SBPafter 1 min of laeyngoscopy in decmedetomedine versus group were 113.2+\\_14.503and 125.92+\\_15.263 respectively,power 95 percent and confidence 95 percent ,The required sample size for the study is 72( 36 ) in each group.\n\nAfter taking informed consent patients are randomly divided into two groups via opaque sealed envelop technique.Half of envelops will be labelled as letter D ,and half will be labelled as letter C .Patients in group D will be nebulized with dexmedetomedine with dose of 1ug/kg made total volume of 5 ml with normal saline.While group C will be nebulized with 5 ml of 0.9 percent normal saline 30 min prior to elective intubation.Hemodynamic parmmeters heart rate ,systolic bp,diastolic bp,MAP will be noted at baseline and 0,1,5,10 min after inrubation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nAge 18-65 years ASAI-III Both genders Patients undergoing elective intubation\n\nExclusion criteria:\n\nPatients with renal hepatic or neurological disease Bleeding diathesis Mallampatti III-IV Previous histoey of difficult intubation.'}, 'identificationModule': {'nctId': 'NCT07480304', 'briefTitle': 'To Evaluate Effect of Nebulized Dexmedetomedine Upon Blunting Autonomic Response of Laeyngoscopy and Intubation in Patients Undergoing Elective Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Dow University of Health Sciences'}, 'officialTitle': 'To Evaluate Effect of Nebulized Dexmedetomedine Upon Blunting Autonomic Response of Laryngoscopy and Intubation in Patients Undergoung Elective Intubation', 'orgStudyIdInfo': {'id': 'IRB4343/DUHS/Approval/2025/479'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomedine nebulization in group D', 'description': 'Dexmedetomedine nebulization done with a dose of1ug /kg 30min prioor to induction of general anaesthesia', 'interventionNames': ['Drug: Nebulization of dexmedetomedine in group D']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal saline nebulization in group C', 'description': 'Normal saline nebulization done 30min prior to induction of general anaesthesia,hemdynamic parameters heart rate,systolic bp,diastolic bp,MAP,will be noted at baseline,0,1,5,10 min after intubation', 'interventionNames': ['Drug: Nebulizition with normal saline in group C,after taking informed consent patients in group cwill be nebulized with 5 ml of normal saline 30 min prior to elective intubation ,HR,SBP,DBP,MAP monitored.']}], 'interventions': [{'name': 'Nebulization of dexmedetomedine in group D', 'type': 'DRUG', 'description': 'After taking informed consent ,patients are divided into 2 groups by using opaque sealed envelop technique ,half envelope were labelled with letter D ,half were labelled with letter patients in group D will be nebulized wirh dexmedetimedine wuth dose of 1ug/kgwith made total volune of 5ml by mixing with norml saline 30 min prior to intubation', 'armGroupLabels': ['Dexmedetomedine nebulization in group D']}, {'name': 'Nebulizition with normal saline in group C,after taking informed consent patients in group cwill be nebulized with 5 ml of normal saline 30 min prior to elective intubation ,HR,SBP,DBP,MAP monitored.', 'type': 'DRUG', 'description': 'Groyp c will be nebulized with normal saline 30 min prior to intubation,hemodynamic parameters heart rate,systolic bp ,diastolic bp,MAP, will be monitored at baseline,0,1,5,10 min after intubation.', 'armGroupLabels': ['Normal saline nebulization in group C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Hafiza Javeria Jawed', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dow University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Hafiza Javeria Jawed', 'investigatorAffiliation': 'Dow University of Health Sciences'}}}}