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CTRI Number  CTRI/2020/04/024711 [Registered on: 17/04/2020] Trial Registered Prospectively
Last Modified On: 16/04/2020
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   A comparison of propofol versus dexmedetomidine in ERCP patients 
Scientific Title of Study   A comparison between continuous infusion of dexmedetomidine and propofol for sedation in patients undergoing Endoscopic retrograde cholangiopancreatography  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrLakshmi Kumar 
Designation  Professor and Head 
Affiliation  Amrita Institute of Medical Sciences ad Research Centre 
Address  Department of Anaesthesia, Tower6, Floor 1, AIMS, Kochi
Amrita lane, Edapally, Kochi 682041
Ernakulam
KERALA
682041
India 
Phone  9496211333  
Fax  04842852020  
Email  lakshmi.k.238@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrLakshmi Kumar 
Designation  Professor and Head 
Affiliation  Amrita Institute of Medical Sciences ad Research Centre 
Address  Department of Anaesthesia, Tower6, Floor 1, AIMS, Kochi
Amrita lane, Edapally, Kochi 682041

KERALA
682041
India 
Phone  9496211333  
Fax  04842852020  
Email  lakshmi.k.238@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrRoopa Manchinabele Nagabhushan 
Designation  Fellow Hepatobiliary and Solid Organ Transplant 
Affiliation  Amrita Institute of Medical Sciences ad Research Centre 
Address  Department of Anaesthesia, Tower6, Floor 1, AIMS, Kochi
Amrita lane, Edapally, Kochi 682041
Ernakulam
KERALA
682041
India 
Phone  9886523983  
Fax  04842852020  
Email  dr.mnroopa@gmail.com  
 
Source of Monetary or Material Support  
Amrita Institute f Medical Sciences Amrita lane, Edapally Kochi 682021 Kerala 
 
Primary Sponsor  
Name  Amrita Institute of Medical Sciences 
Address  Amrita lane, Edapally Kochi 682041 
Type of Sponsor  Research institution and hospital 
 
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 
Lakshmi Kumar  Amrita Institute of Medical Sciences  Department of Anaesthesia , Tower 6, floor 1, Amrita Institute of Medical Sciences, Amrita lane, Edapally Kochi 682041
Ernakulam
KERALA 
9496211333
04842852020
lakshmi.k.238@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amrita Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (3) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine infusion  Infusion of dexmedetomidine, 1 mcg/kg/min over 10 minsfollowed by 0.5mcg/kg/h for achieving satisfactory sedation during ERCP 
Comparator Agent  Propofol infusion  Propofol infusion 1mg/kg over 10 mins followed by 50mcg/kg/min to achieve satisfactory level of sedation during ERCP 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with ASA I to III, belonging to age group 18-65 years scheduled for elective ERCP procedure. 
 
ExclusionCriteria 
Details  1. Duration of procedure >2 hours
2. Severe Cardiac, Pulmonary, CNS and Renal disorders
3. Allergic to study medications.
4.Habituation to Sedative drugs.
5. Morbid obesity.
6.Refusal to participate.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time taken to achieve satisfactory sedation Ramsay sedation Score (RSS 3-4) using an infusion of dexmedetomidine versus propofol infusion  Start of infusion until RSS of 3-4. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Number of times additional boluses are administered and dosing needed.
2.To note the time taken for recovery (from discontinuation of the study drug till achieving Modified Aldrete Score 9-10

3. To look for incidence ofadverse effects hypotension (SBP≤90mm Hg), bradycardia (HR≤50 bpm), desaturation (SpO2≤92 for 10sec) and apnoea (no spontaneous breaths for 10sec) and any interventions.
4. To assess patient and endoscopist satisfaction by a scoring system .
 
Points in time needing additional intervention during the procedure 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   20/04/2020 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Propofol is widely used for conscious sedation procedures in endoscopic retrograde cholangiopancreatography but can sometimes result in apnea during and after the infusion.
Dexmedetomidine is an alpha agonist with sedative effects being used widely in a number of clinical situations. Among its advantages is the preservation of respiration even under sedative doses.

We propose to evaluate the infusion of a standard dose of propofol with infusion dose of dexmedetomidine in achieving a comparable level of sedation in patients undergoing this procedure. We also aim to look at any adverse effects such as hypotension, bradycardia, and apnea during this procedure and the recovery profile of patients in either group.
 
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