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
|
|
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
|
|
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.
|