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CTRI Number  CTRI/2022/07/043892 [Registered on: 11/07/2022] Trial Registered Prospectively
Last Modified On: 07/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two anaesthetic drug as sedative for ERCP  
Scientific Title of Study   Etomidate versus propofol as sedative for ERCP - A prospective randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nitin Mantri  
Designation  Senior resident 
Affiliation  ILBS Hospital,New Delhi  
Address  Department of anaesthesia,ILBS Hospital, New Delhi.

South
DELHI
110070
India 
Phone  9205814561  
Fax    
Email  nitinmantri86@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Udit Dhingra 
Designation  Assistant Professor  
Affiliation  ILBS Hospital,New Delhi  
Address  Department of anaesthesia, ILBS Hospital, New Delhi

South
DELHI
110070
India 
Phone  8861987684  
Fax    
Email  uddh1989@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nitin Mantri 
Designation  Senior Resident  
Affiliation  ILBS Hospital,New Delhi  
Address  Department of Anaesthesia,ILBS Hospital,New Delhi

South
DELHI
110070
India 
Phone  9205814561  
Fax    
Email  nitinmantri86@gmail.com  
 
Source of Monetary or Material Support  
Anaesthesia department,ILBS Hospital,New Delhi  
 
Primary Sponsor  
Name  Nitin mantri  
Address  Department of anaesthesia,Ilbs hospital  
Type of Sponsor  Other [Self] 
 
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 NITIN MANTRI  ILBS HOSPITAL,NEW DELHI  Department of Anaesthesia,ILBS HOSPITAL ,NEW DELHI
South
DELHI 
9205814561

nitinmantri86@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD ILBS HOSPITAL  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: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Etomidate infusion  received etomidate 0.15-0.2 mg/kg over 60 seconds followed by 5 -10 mcg/kg/min through infusion pump. 
Comparator Agent  Propofol  received propofol 1.5-2 mg/kg over 60 seconds followed by 50 - 75 mcg/kg/min through infusion pump 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA grade I -II undergoing ERCP in Institute of Liver and Biliary Sciences New Delhi 
 
ExclusionCriteria 
Details  1.Patient refusal

2.Chronic sedative or opioid analgesic use

3.Known allergy to the study drugs

4.Uncontrolled Hypertension

5.Uncontrolled Diabetes

6.Presence of Cirrhosis (on imaging +/- histology)
7.Post liver transplant recipients

8.Heart failure (ejection fraction <40%,NYHA IV)

9.Severe respiratory disease (FEV1<50%,FVC<50%)

10.Porphyria

11.Pre-existing epilepsy

12.Pregnancy

13.Lactation

14.Procedure more than 60 min

15.Patients with known adrenocortical insufficiency 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine no.of transient hypotension in both groups.


 
3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To determine no. Of transient hypoxia in both groups
Induction time
Recovery time
Any adverse effects  
3 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   13/07/2022 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Endoscopic procedures like ERCP are performed with patient under moderate to deep sedation  

•Sedation reduces patient anxiety, discomfort and pain, enhancing patient cooperation and facilitating the procedure.

•Sedation during endoscopy also minimizes patient’s risk for physical injury during examination and provides the endoscopist with an ideal environment for  thorough examination.

Most patients undergoing ERCP may have obstructive jaundice, which makes them prone to hypotension and bradycardia during sedation.

•Sedation may be defined as a drug-induced depression in the level of consciousness.

•Four stages of sedation have been described, ranging from minimal (anxiolysis) to moderate , deep and general anesthesia.[1] The most common agent used for sedation is propofol as single use or in combination with other medications, because of better pharmacokinetic profile than benzodiazepines or opioids with regard to onset time and recovery time.[2,3] 

 â€¢Although propofol is routinely administered for GI endoscopy, it is associated with several adverse events such as hypoxia, hypotension, arrhythmia and risk of respiratory depression including apnea.[4,5] Etomidate is an  hypnotic agent with rapid onset (5-15 seconds) and recovery (5-15 minutes).[6]

•Etomidate has more stable cardiovascular profile than propofol [12] and minimal respiratory depression.

•Etomidate may causes minor side effects like pain on injection, postoperative nausea andvomiting (PONV), dose‑dependent myoclonus and adrenocortical suppression- gets normalised in 24 hrs. Bispectral index (BIS)[7] is considered a better indicator for depth of anesthesia compared to routine clinical parameters and results in decreased induction dose of anesthetic drug and quick recovery.

•It is a dimensionless number scaled between 0 and 100, with 100 representing awake patient and 0 represent absence of brain activity or electrical silence.

•An optimal value for the maintenance of sedation for endoscopic procedure should be between 60-70.

•Etomidate is mostly used as induction agent in anesthesia,very few studies done in ERCP using  Etomidate as sedative for loading and maintenance.


 
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