| CTRI Number |
CTRI/2024/11/077045 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Methods of Giving Propofol During ERCP with a Special Airway Device |
|
Scientific Title of Study
|
Comparative Study Of Continuous Infusion With Intermittent Bolus Of Propofol During ERCP Using Laryngeal Mask Airway®Gastro™
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshit Dodiya |
| Designation |
Junior Resident |
| Affiliation |
TMU MEDICAL COLLEGE AND HOSPITAL MORADABAD |
| Address |
Room No. 204 Department Of Anaesthesia Teerthanker Mahaveer
Medical College and Research Centre N.H.-24, Delhi Road,
Moradabad - 244001, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India
Moradabad UTTAR PRADESH 244001 India |
| Phone |
9974344765 |
| Fax |
|
| Email |
harshitdodiya765@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pallavi Ahluwalia |
| Designation |
Professor |
| Affiliation |
TMU MEDICAL COLLEGE AND HOSPITAL MORADABAD |
| Address |
Room No. 204 Department Of Anaesthesia Teerthanker Mahaveer
Medical College and Research Centre N.H.-24, Delhi Road,
Moradabad - 244001, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India
Moradabad UTTAR PRADESH 244001 India |
| Phone |
8218628850 |
| Fax |
|
| Email |
pallaviahluwalia22@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Md Shahbaz Alam |
| Designation |
Professor |
| Affiliation |
TMU MEDICAL COLLEGE AND HOSPITAL MORADABAD |
| Address |
Room No. 204 Department Of Anaesthesia Teerthanker Mahaveer
Medical College and Research Centre N.H.-24, Delhi Road,
Moradabad - 244001, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India
Moradabad UTTAR PRADESH 244001 India |
| Phone |
9897907372 |
| Fax |
|
| Email |
dralamshahbaz006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College and Research Centre, Moradabad, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Teerthanker Mahaveer Medical College and Research Centre,
N.H.-24, Delhi Road, Moradabad - 244001, Uttar Pradesh |
| Type of Sponsor |
Private medical college |
|
|
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 Harshit Dodiya |
Teerthanker Mahaveer Medical College and Research Centre |
Room no 4,Department
of Anaesthesia
Moradabad
UTTAR PRADESH Moradabad UTTAR PRADESH |
9974344765
harshitdodiya765@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthanker Mahaveer University-Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuos infusion of propofol using LMA®Gastro™ |
infusion of propofol will be started at 9-12 mg/kg/hr. Depth of anaesthesia will be assessed by loss of eyelash reflex/verbal contact. After induction, the infusion rate will lowered to the range of 2-5 mg/kg/hr then titrated by 1-2mg/kg/hr to maintain adequate sedation |
| Comparator Agent |
Intermittent Bolus injection of propofol using LMA®Gastro™ |
patient will be given intravenous injection bolus 2mg/kg propofol, followed by additional small boluses of 10-20 mg propofol every 30-60 secs to maintain adequate sedation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving informed and written consent
Age 18-60 years
American Society of Anaesthesiologists (ASA) physical status I-II[9]
Patient posted for elective ERCP
|
|
| ExclusionCriteria |
| Details |
Edentulous patient
Mallampati class IV or any Facial deformity
H/O Obstructive sleep apnea
Allergy to propofol ,lipid emulsion or egg lecithin
High risk of aspiration i.e. Gatroesophageal reflux disease
Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare recovery time in both the groups.
To compare the ease of LMA®Gastro™ insertion in both the groups.
|
To compare recovery time in both the groups at 1min,2min,3min,5min,10min,15min,20min,25min and every 5 min afterwards.
To compare the ease of LMA®Gastro™ insertion in both the group at Jaw relaxation of patient, Gagging cough reflex and Patient Movement
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To note time to achieve induction and total dose of propofol required in both the groups.
To evaluate the ease of insertion and success rate of endoscope device through the endoscopic channel provided in LMA®Gastro™ in both the groups.
Time to post anaesthesia care unit discharge between the two groups.
Hemodynamic Parameters in both the groups |
Propofol used in induction in mg (Dose-Propofol-1.5mg to 2.5mg/kg). total dose of propofol will be lowered to 2-5mg/kg/hr then titrated to 1-2mg/kg/hr.
time to insert endoscope via Lma gastro will be noted in seconds.
time taken for PACU discharge will be noted in both groups in minutes 0,5,10,15,20,25,30
Hemodynamic vital parameters will be noted in both the groups 0min,15min,30min,45min,60min,75min,90mins |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
25/11/2024 |
| 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="3" Days="0" |
|
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
|
After getting approval from Institutional Ethical Committee
(IEC),
those patients who are fit in inclusion
criteria will be included in our study and written and informed consent will be
taken. Patient
will be randomized in two groups, (40 in
each group) using computer generated random number table. Group
CI
– Continuos
infusion of propofol using
LMA®Gastro™
Group
IB – Intermittent
Bolus
injection of propofol using
LMA®Gastro™. After shifting the patient to endoscopy room, patient
will be asked to lie down supine with
head in sniffing position. ASA monitors will be attached. Baseline values of heart rate(HR),
systolic blood pressure(SBP),diastolic blood pressure(DBP), and oxygen
saturation will be recorded. Patient
will be preoxygenated with 100% oxygen for 3 minutes.
Patient
will be premedicated with 0.05mg/kg midazolam, 2mcg/kg fentanyl and 0.01mg/kg
glycopyrrolate.
In
the CI group, infusion of propofol will be started at 9-12 mg/kg/hr.
Depth of anaesthesia will be assessed by loss of eyelash reflex/verbal contact.
After induction, the infusion rate will lowered to the range of 2-5 mg/kg/hr
then titrated by 1-2mg/kg/hr to maintain adequate sedation.
In the IB group, patient will be
given intravenous injection bolus 2mg/kg
propofol,
followed by additional small boluses of 10-20 mg propofol every 30-60 secs to
maintain adequate sedation.
Induction
time (in
minutes) and Total Propofol
used for induction (in mg) will be recorded.
Standard insertion technique will
be used to insert the LMA®Gastro™ and endoscope, insertion will be
performed by an experienced anaesthesiologist and the ease of insertion of the LMA®Gastro™
(Jaw Relaxation, Gagging,Cough,Patient Movement)[10], first
attempt success
rate of LMA®Gastro™
insertion will be recorded,
Time to insert endoscope via LMA®Gastro™, and Ease of endoscope insertion
as rated by gastroenterologist (graded as easy or difficult) will be recorded.
Successful insertion of LMA®Gastro™
was defined by a square wave
pattern capnography, symmetrical chest wall expansion and the absence of an
audible oral air leak with a cuff pressure between 0-40 cmH20(Yellow zone). If insertion will not successful after two
attempts, the trachea will be intubated using direct laryngoscopy and the
patient will be excluded from the analysis.
Patient will be ventilated by intermittent positive pressure
ventilation in
supine/ lateral position. At the end of procedure, the LMA®Gastro™
will be removed.
The recovery time was defined as
the time from stopping propofol till the patient is conscious, alert, obeying command and the
airway protective reflexes
have
returned.
Recovery time for successful extubation (in minutes) will be recoded.
Any adverse event like postoperative nausea vomiting ,hypotension, bradycardia, will be recorded till discharge from PACU.
|