[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577686":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":23,"studyPopulation":11,"armGroups":24,"interventions":37,"overallOfficials":11,"centralContacts":47,"locations":57,"responsibleParty":78,"collaborators":11,"id":81,"slug":11,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":11,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":11,"studyType":93,"phases":94,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":60,"whyStopped":11,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Shaheed Mohtarma Benazir Bhutto Institue of Trauma","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Nasal bleeding",null,"At the time of Intubation and Extubation",{"allocation":14,"interventionModel":15,"interventionModelDescription":16,"primaryPurpose":17,"observationalModel":11,"timePerspective":11,"maskingInfo":18},"RANDOMIZED","PARALLEL","Group Xylometazoline will receive xylometazoline nasal drops and Group Adrenaline will receive adrenaline nasal pack","PREVENTION",{"masking":19,"maskingDescription":20,"whoMasked":21},"SINGLE","This study is single blind, assessor is kept blind because participants are difficult to mask due to well distinguished treatment plan.",[22],"OUTCOMES_ASSESSOR","This study is conducting after permission from institutional ethical committee. Participants came for elective OMF surgery under general anesthesia are enrolled in this study who fulfilled the inclusion criteria. Informed consent is taken from the participants. Brief history about demographic data was taken from each participant. All participants are examined for airway assessment, cardiovascular and respiratory examination before undergoing anesthesia. Participants are divided into 2 groups by simple lottery method in group xylometazoline and group adrenaline.\n\nGroup Xylometazoline: receive 3 to 5 drops of 0.1% xylometazoline nasal drops in selected nostril 15 mins before transfer to OT.\n\nGroup Adrenaline: receive intranasal packing with adrenaline soaked gauze piece in selected nostril. Packing is done 15 mins before transfer to OT and removed after 7 to 10 minutes. Proper monitoring of vital signs will be done in preoperative area.\n\nAnesthesia machine and accessories are checked, and drugs including emergency drugs are kept ready. Baseline BP, heart rate, ECG, and peripheral oxygen saturation is obtained and recorded from multipara monitor. All participants are preoxygenated by 100% oxygen for 5 mins. Induction is done with propofol (1%) 2mg\u002Fkg and atracurium 0.5 mg\u002Fkg by senior anesthesiologist present. The anesthetist present in OT is blind to both groups. Laryngoscopy is done by an experienced anesthesiologist using a MAC 3 or 4 blade based on participants' anatomy. Nasotracheal intubation is done by a cuffed lubricated (with lidocaine 2%) nasal tube of appropriate size. Anesthesia is maintained with atracurium 0.1 mg\u002Fkg and isoflurane in 60% O2 at 3L flow.\n\nThe anesthesiologist will record incidence and severity of bleeding at the time of intubation and extubation.\n\nData will be analyzed on SPSS version 20. Chi square test will be used to compare the incidence of nasal bleeding in both groups. Effect modifiers are controlled through stratification of age, gender, diabetes mellitus, hypertension to see the effect of these on the outcome variables. Post stratification chi square test will be applied taking P-value of \\\u003C0.05 as statistically significant.",[25,31],{"label":26,"type":27,"description":28,"interventionNames":29},"Xylometazoline Group","EXPERIMENTAL","Participants in this group will receive xylometazoline nasal drops before nasotracheal intubation",[30],"Drug: 0.1% xylometazoline nasal drops",{"label":32,"type":33,"description":34,"interventionNames":35},"Adrenaline Group","ACTIVE_COMPARATOR","Participants in this group will recieve adrenaline nasal packing before nasotracheal intubation",[36],"Drug: Adrenaline nasal pack",[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"DRUG","0.1% xylometazoline nasal drops","Xylometazoline is direct acting, non selective, adrenergic agonist binding with alpha 1\\&2 receptors, used for vasoconstriction to decrease nasal bleeding.",[26],{"type":39,"name":44,"description":45,"armGroupLabels":46,"otherNames":11},"Adrenaline nasal pack","Adrenaline is direct acting, non selective, adrenergic agonist binding with alpha and beta receptors both, used for vasoconstriction to decrease nasal bleeding.",[32],[48,53],{"name":49,"role":50,"phone":51,"phoneExt":11,"email":52},"Dr Sidra Javed Consultant Anaesthetist, MBBS, FCPS, PAIN FELLOW","CONTACT","+92333 2474831","sidra_dow@yahoo.com",{"name":54,"role":50,"phone":55,"phoneExt":11,"email":56},"Dr Mirza Shahzad Baig Consultant Anaesthetist, MBBS, MCPS, FCPS","+923346441539","drshahzadbaig@hotmail.com",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":11,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Shaheed Mohtarma Benazir Bhutto Institute of Trauma","RECRUITING","Karachi","Sindh","Pakistan","PK",{"type":66,"coordinates":67},"Point",[68,69],67.0104,24.8608,{"lat":69,"lon":68},[72,75],{"name":73,"role":74,"phone":11,"phoneExt":11,"email":11},"Iqra Ashraf, MBBS, FCPS TRAINEE","PRINCIPAL_INVESTIGATOR",{"name":76,"role":77,"phone":11,"phoneExt":11,"email":11},"Sidra Tahir, MBBS, FCPS TRAINEE","SUB_INVESTIGATOR",{"type":74,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"IQRA ASHRAF","Principal Investigator","100577686",false,"NCT06801522","Adrenaline Nasal Pack vs Xylometazoline Nasal Drops During Nasotracheal Intubation","Comparison of the Efficacy of Adrenaline Nasal Pack and Xylometazoline Nasal Drops in Decreasing Nasal Bleeding During Nasotracheal Intubation","Inclusion Criteria:\n\n* ASA 1 and 2\n* Age group between 18-60 years\n* Mallampati score 1 and 2\n* Either gender\n* Participants who undergo elective oromaxillofacial surgery\n\nExclusion Criteria:\n\n* Lack of consent\n* Participants with anticipated difficult airway\n* Participants receiving anticoagulant therapy\n* History of nasal abnormality (nasal surgery, trauma, polyp, obstruction)\n* History of repeated epistaxis\n* History of uncontrolled hypertension, diabetes, pregnancy, and any other cardiac or cerebral events.","ALL","18 Years","60 Years",{"count":91,"type":92},70,"ESTIMATED","INTERVENTIONAL",[95,96],"PHASE2","PHASE3","The goal of this trial is to compare efficacy of xylometazoline nasal drops and adrenaline nasal pack in participants undergoing elective oromaxillofacial surgeries.\n\nThe main question aim to answer is xylometazoline nasal drops better than adrenaline nasal packing in terms of nasal bleeding during nasotracheal intubation. Researchers are comparing 2 groups of participants.\n\nParticipants in group Xylometazoline are receiving 0.1% xylometaxoline nasal drops.\n\nParticipants in group Adrenaline are receiving adrenaline nasal packing.",[99,100],"Nasal Bleeding","Nasotracheal Intubation",[102],"Nasal bleeding, Nasotracheal intubation, adrenaline pack, xylometazoline nasal drops","2025-01-24",{"date":105,"type":106},"2025-01-30","ACTUAL",{"date":108,"type":106},"2024-12-01",{"date":110,"type":92},"2025-05",{"name":5,"class":6},1]