[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100348126":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":40,"locations":48,"responsibleParty":80,"collaborators":25,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":25,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":25,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":25,"overallStatus":50,"whyStopped":25,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Sir Ganga Ram Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ETT Group","ACTIVE_COMPARATOR","Anesthesia will be induced with fentanyl-citrate (3µg\u002Fkg) and propofol (dose determined by automated system based on continuous BIS feedback from the patients). Atracurium besylate 0.5-mg\u002Fkg will be given to facilitate placement of airway device. Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA.\n\nIntraoperative ventilation will be instituted through a polyvinyl chloride (PVC) ETT (Portex, Smiths Medical ASD, Inc, Minneapolis, USA). The size of the tube will be standardized for the male (7.5 mm ID) and the female (6.5 MM ID).",[13],"Device: Endotracheal tube (ETT)",{"label":15,"type":10,"description":16,"interventionNames":17},"PLMA Group","Anesthesia will be induced with fentanyl-citrate (3µg\u002Fkg) and propofol (dose determined by automated system based on continuous BIS feedback from the patients). Atracurium besylate 0.5-mg\u002Fkg will be given to facilitate placement of airway device. Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA. intraoperative ventilation will be maintained with PLMA (Telefex Medical, Westmeath Ireland) whose size would be selected based on body weight. In patients weighing 30-50 kg PLMA # 3.0, 50-70 kg PLMA # 4.0, and 50-100 kg PLMA # 5.0 will be inserted.",[18],"Device: ProSeal Laryngeal Mask Airway (PLMA)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Endotracheal tube (ETT)","After induction of anaesthesia patient will be intubated with polyvinyl chloride (PVC) ETT for maintaining intraoperative ventilation. Anaesthesia will be maintained with propofol and the administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"ProSeal Laryngeal Mask Airway (PLMA)","After induction of anaesthesia ProSeal Laryngeal Mask Airway (PLMA) will be inserted for maintaining intraoperative ventilation. Anaesthesia will be maintained with propofol and the administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA.",[15],[31,34,37],{"name":32,"affiliation":5,"role":33},"Nitin Sethi, DNB","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":36},"Amitabh Dutta, MD","STUDY_DIRECTOR",{"name":38,"affiliation":5,"role":39},"Jayashree Sood, MD, FFRCA","STUDY_CHAIR",[41,45],{"name":32,"role":42,"phone":43,"phoneExt":25,"email":44},"CONTACT","00919717494498","nitinsethi77@yahoo.co.in",{"name":35,"role":42,"phone":46,"phoneExt":25,"email":47},"+911142252523","duttaamiatbh@yahoo.co.in",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","New Delhi","National Capital Territory of Delhi","110060","India","IN",{"type":57,"coordinates":58},"Point",[59,60],77.2148,28.62137,{"lat":60,"lon":59},[63,64,65,66,67,69,72,74,76,78],{"name":32,"role":42,"phone":46,"phoneExt":25,"email":44},{"name":35,"role":42,"phone":46,"phoneExt":25,"email":47},{"name":32,"role":33,"phone":25,"phoneExt":25,"email":25},{"name":35,"role":33,"phone":25,"phoneExt":25,"email":25},{"name":68,"role":33,"phone":25,"phoneExt":25,"email":25},"Goverdhan D Puri, MD,PhD",{"name":70,"role":71,"phone":25,"phoneExt":25,"email":25},"Jayashree Sood, MD,FFRCA","SUB_INVESTIGATOR",{"name":73,"role":71,"phone":25,"phoneExt":25,"email":25},"Bhuwan C Panday, MD",{"name":75,"role":71,"phone":25,"phoneExt":25,"email":25},"Prabhat K Choudhary, MD",{"name":77,"role":71,"phone":25,"phoneExt":25,"email":25},"Manish Gupta, MD",{"name":79,"role":71,"phone":25,"phoneExt":25,"email":25},"Savitar Malhotra, MD",{"type":33,"investigatorFullName":32,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Consultant & Associate Professor","100348126","comparison-of-anaesthesia-requirement-for-ventilation-with-endotracheal-tube-versus-proseal-laryngeal-mask-airway-100348126",false,"NCT03812718","Comparison of Anaesthesia Requirement for Ventilation With Endotracheal Tube Versus Proseal Laryngeal Mask Airway","Anaesthesia Requirements for Ventilation With Endotracheal Tube Versus ProSeal Laryngeal Mask Airway During Automated Feedback-Loop Controlled Total Intravenous Anaesthesia in Patients Undergoing Laparoscopic Cholecystectomy: A Randomised Controlled Study","Inclusion Criteria:\n\n1. ASA physical status I\u002FII\n2. Undergoing elective laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n1. Anticipated difficult airway\n2. Body mass index \\> 30-kg\u002Fm2\n3. Uncompensated cardiovascular disease (e.g. uncontrolled hypertension, atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance, diastolic dysfunction)\n4. Hepato-renal insufficiency\n5. Uncontrolled endocrinology disease (e.g. diabetes mellitus, hypothyroidism)\n6. Known allergy\u002Fhypersensitivity to the study drug (propofol)\n7. Drug dependence\u002Fsubstance abuse\u002Fpsychiatric illness\n8. Requirement of postoperative ventilation\n9. Refusal to informed consent","ALL","18 Years","65 Years",{"count":93,"type":94},160,"ESTIMATED","INTERVENTIONAL",[97],"NA","Endotracheal tube (ETT) is the gold standard conduit for providing controlled ventilation during general anaesthesia (GA). however, the supra-glottic airway (SGA) devices in particular the laryngeal mask airway (LMA) and its variants have become a reliable alternative to ETT for carrying out controlled ventilation. Of the several variants of LMA available today, the proseal LMA (PLMA) is preferred for controlled ventilation. The various advantages of LMA includes, a lower incidence of postoperative sore throat and superior haemodynamic profile during surgery. However, one aspect of providing anaesthesia with LMA compared to ETT is the ability of LMA to maintain equivalent depth of anaesthesia with lower anaesthetic requirement, is quiet intriguing and evidence to this regard is very limited.\n\nBy measuring the anaesthesia requirement using a robust computerised delivery system such as the closed loop anaesthesia delivery system (CLADS) we can establish for sure the anaesthesia required for maintaining intraoperative mechanical ventilation with the use of these two (ETT and PLMA) airway management devices.\n\nThis randomised controlled study aims to calculate the anaesthesia requirement as determined by the total amount of propofol consumed for maintaining anaesthesia with ETT versus PLMA",[100,101],"Cholelithiases","Cholecystolithiasis","2026-04-22",{"date":104,"type":105},"2026-04-27","ACTUAL",{"date":107,"type":105},"2019-03-04",{"date":109,"type":94},"2026-12",{"name":5,"class":6},1]