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CTRI Number  CTRI/2024/06/068267 [Registered on: 03/06/2024] Trial Registered Prospectively
Last Modified On: 31/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between two drugs for sedation in endoscopic procedures. 
Scientific Title of Study   Sedation in upper GI endoscopic procedures A comparison between propofol and dexmedetomidine 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arnab Roy 
Designation  PGT Anaesthesiology 
Affiliation  Institute Of Post Graduate Medical Education and Research Kolkata  
Address  Department of Anaesthesiology. IPGMER&SSKM Hospital 244, A.J.C. Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  8282801572  
Fax    
Email  arnabrroy0007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Tapas Ghose 
Designation  Professor, Department of GI Anaesthesiology,  
Affiliation  Institute Of Post Graduate Medical Education and Research Kolkata  
Address  School of Digestive & Liver Disease IPGMER & SSKM Hospital 244, A.J.C. Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  8282801572  
Fax    
Email  g.tapas@gmail.com  
 
Details of Contact Person
Public Query  
Name  Arnab Roy 
Designation  PGT Anaesthesiology 
Affiliation  Institute Of Post Graduate Medical Education and Research Kolkata  
Address  Department of Anaesthesiology. IPGMER&SSKM Hospital 244, A.J.C. Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  8282801572  
Fax    
Email  arnabrroy0007@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology. IPGMER & SSKM Hospital 244, A.J.C. Bose Road, Kolkata ,PIN 700020 
 
Primary Sponsor  
Name  The Institute of Post Graduate Medical Education and Research 
Address  244, A.J.C. Bose Road, Kolkata 700 020 
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 Arnab Roy  Institute of Post Graduate Medical Education and Research  Department of Anaesthesiology. 3rd Floor, Main Block. 244, A.J.C. Bose Road, Kolkata 700 020
Kolkata
WEST BENGAL 		 8282801572

arnabrroy0007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Postgraduate Medical Education & Research [IPGME&R] Kolkata-700020  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Administration of dexmedetomidine  Administration of intravenous dexmedetomidine given initially with a loading dose of 1mcg/kg for 6-10 minutes followed by maintenance dose of 0.2-1.4mcg/kg/hr. 
Comparator Agent  Administration of propofol  Administration of propofol given intravenous with an initial loading bolus of 0.5-1mg/kg followed by titrating doses. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients between 18 to 60 years either gender. Patients undergoing therpeutic upper GI endoscopies. No major comorbidity. 
 
ExclusionCriteria 
Details  Patients refusing consent. Patients with major cardio respiratory comorbidities. Obesity. Hypersensitivity to study drugs. Previously failed upper GI endoscopic procedures. Patients with ongoing upper GI bleed. Patients with airway abnormalities. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Intravenous dexmedetomidine can be a suitable alternative for sedation in comparison to intravenous propofol.  During Upper GI endoscopic procedures. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of peri procedural hemodynamic stability in upper GI endoscopic procedures while using intravenous dexmedetomidine & intravenous propofol.  During Upper GI endoscopic procedures. 
Assessment of peri procedural obtundation of airway reflex in upper GI endoscopic procedures while using intravenous dexmedetomidine & intravenous propofol.  During Upper GI endoscopic procedures. 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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 4 
Date of First Enrollment (India)   17/06/2024 
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="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Diagnostic and therapeutic endoscopy is a routine and often challenging procedure taken up by gastroenterologists to perform different clinical procedures and diagnostic test. Patients often require moderate to deep sedation in order to tolerate manipulation of the endoscope. In this study we will compared the adequacy of sedation, hemodynamic stability, obtundation of airway reflex, breakthrough awakening and post procedure recovery and recall between propofol and dexmedetomidine. 
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