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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/2014/10/005092 |
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Date of registration:
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13-10-2014 |
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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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Comparison of Dexmedetomidine with Midazolam for sedation in geriatric patients.
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Scientific title:
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COMPARISON OF DEXMEDETOMIDINE WITH MIDAZOLAM FOR SEDATION IN ELDERLY PATIENTS UNDERGOING REGIONAL ANAESTHESIA |
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Date of first enrolment:
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12-03-2014 |
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Target sample size:
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100 |
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Recruitment status: |
Closed to Recruitment of Participants |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8825 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group Trial
Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Other Blinding and masking:Participant and Investigator 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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SHAIKH MOHD MUDASSSIR
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Address:
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Department of Anaesthesia,
Saifee Hospital,, Mumbai DEPARTMENT OF ANAESTHESIA
8TH FLOOR SAIFEE HOSPITAL
MAHARISHI KARVE MARG
CHARNI ROAD MUMBAI.
400004
Mumbai, MAHARASHTRA
India |
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Telephone:
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9821428046 |
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Email:
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tsdhansura@yahoo.co.in |
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Affiliation:
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SAIFEE HOSPITAL |
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Name:
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Dr Tasneem Dhansura
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Address:
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Department of Anaesthesia,
Saifee Hospital,
Mumbai, DEPARTMENT OF ANAESTHESIA
8TH FLOOR SAIFEE HOSPITAL
MAHARISHI KARVE MARG
CHARNI ROAD MUMBAI.
400004
Mumbai, MAHARASHTRA
India |
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Telephone:
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9821428046 |
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Email:
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tsdhansura@yahoo.co.in |
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Affiliation:
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SAIFEE HOSPITAL |
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Key inclusion & exclusion criteria
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Inclusion criteria: ALL AMERICAN SOCIETY OF ANAESTHESIOLOGISTS GRADE 1 AND 2 PATIENTS ABOVE 60 YEARS OF AGE WHO ARE SCHEDULED FOR ELECTVE SURGERIES UNDER REGIONAL ANAESTHESIA ARE INCLUDED IN STUDY.
Exclusion criteria: 1)ALLERGIC REACTIONS TO STUDY DRUGS
2)SEVERE HEPATIC OR RENAL DYSFUNCTION
3)OBESE PATIENTS WITH BMI >30
4)PATIENTS ON CHRONIC TREATMENT WIHT SEDATIVE DRUGS
5)PATIENTS WITH SEVERE CARDIAC DISEASES
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- AMERICAN SOCIETY OF ANAESTHESIOLOGIST GRADE 1 AND 2 PATIENTS.
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Intervention(s)
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Intervention1: Dexmedetomidine: Effect of dexmedetomidine 0.5 mic/kg bolus over 10 mins followed by infusion 0.2mic/kg on sedation in elderly patients undergoing regional anaesthesia.
Control Intervention1: MIDAZOLAM: Comparison with effects of midazolam 1mg bolus followed by 0.01mg/kg every 30 mins intravenously on sedation in elderly patients undergoing regional anaesthesia
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Primary Outcome(s)
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QUALITY OF SEDATION AS MEASURED BY RAMSAY SEDATION SCORE AND HEMODYNAMIC STABILITYTimepoint: QUALITY OF SEDATION AS MEASURED BY RAMSAY SEDATION SCORE AND HEMODYNAMIC STABILITY
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Secondary Outcome(s)
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PATIENT SATISFACTIONTimepoint: GOOD OR BAD
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Source(s) of Monetary Support
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SELF
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Ethics review
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Status: Approved
Approval date: 20/03/2013
Contact:
saifee hospital ethics commitee
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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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