Clinical Trial Details (PDF Generation Date :- Fri, 03 Sep 2021 20:08:19 GMT)

PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Fri, 24 Sep 2021 13:13:08 GMT)

CTRI Number CTRI/2018/08/015250 [Registered on: 09/08/2018] - Trial Registered Prospectively Last Modified On 21/09/2020 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 To study the effect of pain killer drug called Clonidine with bupivacaine in anaesthesia given to back(spinal anaesthesia) in caesarean sections surgeries for pain relief. Scientific Title of efficacy of intrathecal clonidine as an adjuvant to hyperbaric bupivacaine in caesarean section : an Study open labelled randomized control trial Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Swati Sujeer Trial Coordinator (multi-center study) Designation anaesthesia resident Affiliation bangalore baptist hospital Address department of anaesthesia, bangalore baptist hospital, bellary road, bangalore, karnataka - 560024 department of anaesthesia, bangalore baptist hospital, bellary road, bangalore, karnataka - 560024 Bangalore KARNATAKA 560024 India Phone 9900610221 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Reena K Query) Designation consultant Affiliation bangalore baptist hospital Address bangalore baptist hospital, bellary road, bangalore, karnataka - 560024 bangalore baptist hospital, bellary road, bangalore, karnataka - 560024 Bangalore KARNATAKA 560024 India Phone 9900610221 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Swati Sujeer Designation anaesthesia resident Affiliation bangalore baptist hospital Address department of anaesthesia, bangalore baptist hospital, bellary road, bangalore, karnataka - 560024 department of anaesthesia, bangalore baptist hospital, bellary road, bangalore, karnataka -

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560024 Bangalore KARNATAKA 560024 India Phone 9900610221 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > department of anaesthesia,bangalore baptist hospital, bellary road, hebbal, karnataka-560024 Primary Sponsor Primary Sponsor Details Name bangalore baptist hospital Address bangalore baptist hospital, bellary road, bangalore, karnataka - 560024 Type of Sponsor Other [mission hospital] 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 SWATI SUJEER BANGALORE BAPTIST department of 9900610221 HOSPITAL anaesthesia, BANGALORE BAPTIST [email protected] HOSPITAL, BELLARY m ROAD, HEBBAL, BANGALORE- 560024 Bangalore KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? IRB, bangalore baptist Approved 30/01/2018 No hospital Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Encounter for cesarean delivery without indication Patients Encounter for cesarean delivery without indication Intervention / Type Name Details Comparator Agent Intervention plain hyperbaric bupivacaine 12 mg of hyperbaric bupivacaine will be administered intrathecally, once before caesarean section. Comparator Agent clonidine with bupivacaine clonidine 30 micrograms with hyperbaric. hyperbaric bupivacaine 10 mg will be administered intrathecally once, just before caesarean section. Inclusion Criteria Inclusion Criteria

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Age From 18.00 Year(s) Age To 45.00 Year(s) Gender Female Details 1. Previous LSCS.
2. Cephalo-pelvic disproportion
3. Failure of progression of labour.
4. Abnormal foetal presentation
Exclusion Criteria Exclusion Criteria Details 1. Patients refusal to participate 2. Pregnancy induced hypertension 3. Placenta previa. 4. Antenatal patients with acute fetal distress. 5. Abnormal coagulation profile

Method of Generating Computer generated randomization Random Sequence Method of An Open list of random numbers Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Primary objective: to compare onset and duration of sensory To compare the duration of sensory block, motor block,motor block and analgesia every 5 mins till block and analgesia in hyperbaric bupivacaine end of surgery, then every 15 mins till first dose versus hyperbaric bupivacaine with clonidine as of rescue analgesia additive in lower segment caesarean sections.

Secondary Outcome Outcome Timepoints 1. Comparison of regression of motor block to every 15 mins pain score assessed using visual modified Bromage scale 0 analogue score till dose of first rescue analgesia. 2. Comparison of duration of pain relief (first request for supplemental analgesia), hemodynamic variables and sedation. 3. Comparison of Apgar score of the babies at 1, 5 and 10 minutes (neonatal outcome).

Target Sample Size Total Sample Size=98 Sample Size from India=98 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 Phase 1 Date of First 10/08/2018 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Closed to Recruitment of Participants Trial (Global) Recruitment Status of Closed to Recruitment of Participants Trial (India) Publication Details none yet Brief Summary to the study the analgesic effect of clonidine intrathecal in caesarean sections. to compare onset times, duration of analgesic effects and sedation scores with clonidine as additive.

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