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
|
|
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
|
|
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] •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. |