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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 00:41:18 GMT) CTRI Number CTRI/2020/06/025642 [Registered on: 05/06/2020] - Trial Registered Prospectively Last Modified On 26/05/2020 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Other (Specify) [LARYNGOSCOPE] Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study Comparision Of, Changes in Body, During Intubation In Raised Blood Pressure Patient By Using Different Laryngoscope Scientific Title of Comparative study of Hemodynamic response during Laryngoscopy and Endotracheal Intubation Study with MacIntosh, MacCoy and King Vision Video Laryngoscope in Controlled Hypertensive Patients Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name URMILA PALARIA Trial Coordinator (multi-center study) Designation Professor Affiliation Government Medical College, Haldwani Address Dr Urmila Palaria, Department Of Anaesthesiology Critical Care Pain And Palliative Medicine, Government Medical College Rampur Road, Haldwani, Nainital, 263139 Uttarakhand India Nainital UTTARANCHAL 263139 India Phone 9897088443 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Urmila Palaria Query) Designation Professor Affiliation Government Medical College, Haldwani Address Dr Urmila Palaria, Department Of Anaesthesiology Critical Care Pain And Palliative Medicine, Government Medical College , Rampur Road, Haldwani, Nainital 263139 Uttarakhand India Nainital UTTARANCHAL 263139 India Phone 9897088443 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Urmila Palaria Designation Professor Affiliation Government Medical College, Haldwani Address Dr Urmila Palaria, Department Of Anaesthesiology Critical Care Pain And Palliative Medicine, Government Medical College , Rampur Road, Haldwani, Nainital, Uttarakhand 263139 India Nainital UTTARANCHAL page 1 / 3 PDF of Trial CTRI Website URL - http://ctri.nic.in 263139 India Phone 9897088443 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Pramita Address- SR Hostel Room No. 72 Government Medical College Haldwani Nainital Uttarakhand 263139 Primary Sponsor Primary Sponsor Details Name Dr Pramita Address GMC Haldwani Campus SR Hostel Room No 72 Nainital Uttarakhand Type of Sponsor Government medical college Details of Secondary Name Address Sponsor self self Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Pramita Susheela Tiwari Department Of 9760269161 Hospital Government Anaesthesiology Critical Medical College Care Pain And dr.pramitatamta92@gm Haldwani Nainital , Palliative Care ail.com Uttarakhand Medicine Nainital UTTARANCHAL Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? INSTITUTIONAL Approved 15/01/2019 No ETHICAL COMMITTEE .GOVERNMENT MEDICAL COLLEGE HALDWANI NAINITAL UTTARAKHAND Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Calculus of gallbladder with acutecholecystitis Intervention / Type Name Details Comparator Agent Intervention Laryngoscope MaCintosh, MaCCoy and King Vision Video Laryngoscope Inclusion Criteria Inclusion Criteria Age From 20.00 Year(s) Age To 50.00 Year(s) Gender Both Details 1.ASA Grade I and II<br/> 2.MPS Grade I and II. <br/> 3.Patients with controlled hypertension<br/> 4.Age >20 year and <50 year <br/> 5.Body mass index <30Kg/m2<br/> 7.Surgery lasting for 1-2 hrs,<br/> 8. Elective surgery under general anaesthesia requiring endotracheal intubation<br/> page 2 / 3 PDF of Trial CTRI Website URL - http://ctri.nic.in Exclusion Criteria Exclusion Criteria Details 1. Patients refusal 2. ASA Grade III & IV 3. MPS III & IV 4. Anticipated difficult airway 5. Laryngoscopy lasted for>30 sec and requirment of > one attempts 6. Severe Cardio-Respiratory comorbidity 7. Hepatorenal disease 8. Neuropsychiatric disease 9. Endocrinal disease 10. Emergency surguries 11. Gastro-oesophageal reflux disease (GERD/GORD) 12. Pregnant patient 13. Body mass index >30 Kg/m2) Method of Generating Computer generated randomization Random Sequence Method of An Open list of random numbers Concealment Blinding/Masking Participant Blinded Primary Outcome Outcome Timepoints To Assess The Hemodynamic Responses Like, Baseline, 1 minutes , 2 minutes, 5 minutes, 10 Heart Rate, Systolic Blood Pressure, Diastolic minutes Blood Pressure And Mean Arterial Pressure, Spo2 ,Ecg (Arrhythmias, St –Segment Change Etc) After Endotracheal Intubation Secondary Outcome Outcome Timepoints 1. To Assess Time For Laryngoscopy Baseline, 1 minute, 2 minute, 5 minute , 10 2. To Assess Time For Intubation minute 3. To Assess The Postoperative Complications, if any. Target Sample Size Total Sample Size=102 Sample Size from India=102 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 09/06/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details Nil Brief Summary To compare the hemodynamic response during laryngoscope and endotracheal intubation with MacIntosh, MacCoy and king Vision Video Laryngoscope in Controlled Hypertensive Patients its a prospective , single blind study page 3 / 3 Powered by TCPDF (www.tcpdf.org).
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