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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2016/01/006573 |
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Date of registration:
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28-01-2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A clinical trial to find the incidence of patients being awake during surgery (awareness)when operations are done on close to their spinal cord.
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Scientific title:
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Awareness during Anaesthesia for spine surgery
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Date of first enrolment:
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01-12-2008 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=772 |
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Study type:
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Observational |
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Study design:
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Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Pritish John Korula
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Address:
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Dept of Surgical ICU, Christian Medical College, Vellore , India 04162282105
632002
Vellore, TAMIL NADU
India |
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Telephone:
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04162282105 |
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Email:
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grace.korula@gmail.com |
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Affiliation:
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Dept of Anaesthesia |
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Name:
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Grace Korula
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Address:
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Christian Medical College and Hospital, Vellore
632002
Vellore, TAMIL NADU
India |
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Telephone:
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04162282105 |
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Email:
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grace.korula@gmail.com |
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Affiliation:
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Dept of Anaesthesia |
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Key inclusion & exclusion criteria
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Inclusion criteria: pts undergoing SSRP/MEP monitoring
Exclusion criteria: pts on beta blockers,uncooerative,pts who cannot communicate
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- incidence of awareness in patietnts undergoing evoked potential monitoring during excision of tumours around the spinal cord
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Primary Outcome(s)
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AwarenessTimepoint: 24 hours within completion of Surgery
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Secondary Outcome(s)
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Comparison between clinical diagnosis of awareness intraop and BIS monitoringTimepoint: During surgery
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Source(s) of Monetary Support
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FLUID RESEARCH GRANT OF CHRISTIAN MEDICAL COLLEGE RESEARCH DEPARTMENT
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Ethics review
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Status: Approved
Approval date: 13/10/2008
Contact:
CMC IRB ethics committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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