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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®Gastroâ„¢  
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  
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 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  
Status 
Not Applicable 
 
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®Gastroâ„¢   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®Gastroâ„¢  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®Gastroâ„¢ 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. 



 
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