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CTRI Number  CTRI/2021/06/033926 [Registered on: 01/06/2021] Trial Registered Prospectively
Last Modified On: 26/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Single Arm Study 
Public Title of Study   Study of patients recovery after anaesthesia by a drug called dexmedetomidine after gastrointestinal endoscopic procedures using two simple pen and paper test 1) trieger dot test 2) digit symbol substitution test  
Scientific Title of Study   Study of duration of psychomotor recovery using Trieger dot test (TDT) and Digit symbol substitution test (DSST) after intravenous Dexmedetomidine infusion as a part of Total intravenous anaesthesia technique in patients undergoing Gastrointestinal endoscopic procedures  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shantanu Marketkar  
Designation  Junior Resident in MD Anaestheisa  
Affiliation  Lokmanya tilak municipal medical college  
Address  Department of anaesthesia Lokmanya tilak municipal medical college, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9892416778  
Fax    
Email  shaanmarks@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shantanu Kulkarni  
Designation  Associate professor 
Affiliation  Lokmanya tilak municipal medical college  
Address  Department of anaesthesia Lokmanya tilak municipal medical college, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9869100774  
Fax    
Email  drshan70@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shantanu Marketkar  
Designation  Junior Resident in MD Anaestheisa  
Affiliation  Lokmanya tilak municipal medical college  
Address  Department of anaesthesia Lokmanya tilak municipal medical college, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9892416778  
Fax    
Email  shaanmarks@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya tilak municipal medical college and hospital, Sion 
 
Primary Sponsor  
Name  Lokmanya Tilak municipal medical college  
Address  Lokmanya tilak municipal medical college and hospital ,sion, mumbai 400022 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shantanu Marketkar   GI endoscopy procedure room , LTMMC,sion hospital  1st floor endoscopy room, dept of gastroenterology,college building,LTMMC & Sion hospital, Sion (e) 400022
Mumbai
MAHARASHTRA 		 9892416778

shaanmarks@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee human research LTMMC,Sion   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  GI endoscopic patients  
 
ExclusionCriteria 
Details  Pregnant, alcoholic , drug abuse  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)To assess psychomotor recovery using Trieger Dot Test and score the patient on number of dots missed,maximum distance of dots missed,average number of dots missed
2) To assess psychomotor recovery using Digit symbol substitution test and score the patient based on correct answers in 90 secs
3) Compare Trieger dot test and Digit symbol substitution test scores with and without dexmedetomidine infusion
4) To document the beneficial effect of dexmedetomidine on early psychomotor recovery 		 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
To document beneficial effect of dexmedetomidine on early psychomotor recovery   3 months  
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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 Enrollment (India)   01/06/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The need for daycare surgeries has increased many folds since past few years due to its early short hospital stay and swift recovery. Psychomotor disturbances occur quite commonly in patients undergoing short procedures like endoscopy under sedation or GA. Thus the primary aim of day-care endoscopic units is to allow for early recovery of the patients so that they can return to their routine activity; the management hence should be focused towards achieving these ends. It can be hypothesised that postoperative psychomotor recovery from anaesthesia would be better if dexmedetomidine is used as adjunct to total intravenous anesthesia TIVA technique. Hence the study to assess psychomotor recovery using Trieger dot test and DSST after intravenous Dexmedetomidine infusion as a part of TIVA technique compared with when dexmedetomidine is not given in patients undergoing endoscopic procedures with anticipated duration less than 2 hours
 
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