PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 15:24:08 GMT) CTRI Number CTRI/2019/03/018052 [Registered on: 12/03/2019] - Trial Registered Prospectively Last Modified On 09/03/2019 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Surgical/Anesthesia Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study A study to find out how many patients develop hearing loss after getting spinal anaesthesia with different sizes and types of spinal needles. Scientific Title of A randomized controlled double blinded study comparing the incidence of hearing loss following Study subarachnoid block with pencil point needle and two different sizes of Quincke’s needle?. Secondary IDs if Any Secondary ID Identifier Details of Principal Details of Principal Investigator Investigator or overall Name K Priyadharshini Trial Coordinator (multi-center study) Designation Post graduate Affiliation Shri Sathya Sai Medical College and Research Institute Address Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road, Ammapettai, Nellikuppam, Kancheepuram 603108 Tamil Nadu, India Kancheepuram TAMIL NADU 603108 India Phone 9894395131 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Vinod Krishnagopal Query) Designation Professor Affiliation Shri Sathya Sai Medical College and Research Institute Address Department of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road, Ammapettai, Nellikuppam, Kancheepuram 603108 Tamil Nadu, India Kancheepuram TAMIL NADU 603108 India Phone 9841557566 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name K Priyadharshini Designation Post graduate Affiliation Shri Sathya Sai Medical College and Research Institute Address Department of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road, Ammapettai, Nellikuppam, Kancheepuram 603108 Tamil Nadu, India Kancheepuram TAMIL NADU page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in 603108 India Phone 9894395131 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram 603108 Tamil Nadu India Primary Sponsor Primary Sponsor Details Name K Priyadharshini Address 74/81,Srinivasa nagar, sakkottai post, kumbakonam 612401 Thanjavur district Type of Sponsor Other [principal investigator] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator K Priyadharshini Shri Sathya Sai Medical Surgery OT 2nd Floor 9894395131 College and Research Operation Theatre Institute Complex Thiruporur [email protected] Guduvanchery main m road, Ammapettai, Nellikuppam, Kancheepuram 603108 Kancheepuram TAMIL NADU K Priyadharshini Shri Sathya Sai Medical ENT Audiometry room 9894395131 College and Research 1st Floor ENT OPD Institute Thiruporur [email protected] Guduvanchery main m road, Ammapettai, Nellikuppam, Kancheepuram 603108 Kancheepuram TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institute Human Ethics Approved 25/01/2019 No Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Disease of digestive system, unspecified Patients Other diseases of the urinary system Patients Unspecified abdominal hernia Intervention / Type Name Details Comparator Agent Intervention 23 gauge quinckes babcock used to Inject 2.4ml of 0.5% spinal needle Bupivacaine hyperbaric intrathecally once. page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Intervention 27 gauge quinckes babcock used to Inject 2.4ml of 0.5% spinal needle Bupivacaine hyperbaric intrathecally once. Intervention 27 gauge pencil point spinal used to Inject 2.4ml of 0.5% needle Bupivacaine hyperbaric intrathecally once. Comparator Agent NIL NIL Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 60.00 Year(s) Gender Both Details 1. Patient posted for lower abdominal surgeries and perineal surgeries under spinal anaesthesia Exclusion Criteria Exclusion Criteria Details 1. ASA III and above physical status 2. History of existing hearing disorders(otitis media, Meniere’s disease) 3. History of any hearing disorders during preanaesthestic assessment confirmed by audiometry 4.Previously existing but undiagnosed hearing loss 5. On ototoxic medications 6. History of chronic headache,migraine,tinnitus 7. History of cardiac disease 8. History of coagulopathies 9. Emergency surgeries 10. pregnancy 11. Previous history of head injury 12. Not willing for audiometry Method of Generating Computer generated randomization Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Participant and Investigator Blinded Primary Outcome Outcome Timepoints To compare the occurence of hearing loss by Post operative period after spinal anaesthesia pure tone audiometry Secondary Outcome Outcome Timepoints To find the incidence of post dural puncture Post operative period after spinal anaesthesia headache Target Sample Size Total Sample Size=66 Sample Size from India=66 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 12/03/2019 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) page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Recruitment Status of Not Yet Recruiting Trial (India) Publication Details None yet Brief Summary This is a randomized controlled double blinded study to compare the occurence of hearing loss following spinal anaesthesia between two sizes of quinckes babcock needle and 27 gauge size pencil point needle among 66 patients undergoing subarachnoid block for lower abdominal and perineal surgeries. The primary outcome of this study is to compare the occurence of hearing loss by pure tone audiometry and the secondary outcome is to find the incidence of post dural puncture headache. page 4 / 4 Powered by TCPDF (www.tcpdf.org).