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CTRI Number  CTRI/2024/06/068624 [Registered on: 10/06/2024] Trial Registered Prospectively
Last Modified On: 09/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A trial comparing addition of lignocaine or ketamine to propofol for sedation during endoscopic procedures. 
Scientific Title of Study   Lignocaine versus ketamine as an adjunct to propofol for optimal sedation during endoscopic retrograde cholangiopancreatography ERCP a 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  AJISHA ARAVINDAN  
Designation  Assistant Professor  
Affiliation  All India institute of medical sciences, New Delhi 
Address  Dept of Anaesthesiology, Pain Medicine and Critical Care, 5th Floor, Academic Block, AIIMS, Ansari Nagar, New Delhi

South West
DELHI
110029
India 
Phone  9810597276  
Fax    
Email  ajishaa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Priyankar Kumar Datta  
Designation  Assistant Professor  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Dept of Anaesthesiology, Pain Medicine and Critical Care, 5th Floor, Academic Block, AIIMS, Ansari Nagar, New Delhi

South West
DELHI
110029
India 
Phone  9830771756  
Fax    
Email  Priyankar.k.datta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Soumya Sundaresh 
Designation  Junior Resident Post graduate 
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Dept of Anaesthesiology, Pain Medicine and Critical Care, 5th Floor, Academic Block, AIIMS, Ansari Nagar, New Delhi

South West
DELHI
110029
India 
Phone  8971014014  
Fax    
Email  soumyasundaresh@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  AIIMS, Ansari Nagar, New Delhi 110029  
Type of Sponsor  Government 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 Ajisha Aravindan  AIIMS New Delhi  EM2, OT2, Endoscopy suite, Department of Gastroenterology
South West
DELHI 
9810597276

Ajishaa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institute Ethics Committee  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 
Comparator Agent  Ketamine infusion  Before starting the endoscopy procedure patients will receive ketamine (1: 10mg dilution) 0.5 mg/kg IV followed by propofol 1 mg/kg IV. More up-titration with 0.5mg/kg boluses of propofol will be done till Ramsay Sedation Score of ≥ 5 is achieved. Sedation will be maintained with separate infusions of ketamine 0.5 mg/kg/hr IV and propofol 5 mg/kg/hr IV till the end of procedure.  
Intervention  Lignocaine infusion  Before starting the endoscopy procedure patients will receive a loading dose of lignocaine (1:20 mg dilution) 1.0 mg/kg IV and a bolus dose of propofol 1.0 mg/kg IV. More up-titration with 0.5mg/kg boluses of propofol will be done till a Ramsay Sedation Score of ≥ 5 is achieved. Sedation will be maintained with 2 separate infusions of lignocaine 1.0 mg/kg/hr and propofol 5 mg/kg/hr till the end of procedure. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists physical status 1 and 2 
 
ExclusionCriteria 
Details  Refusal of consent
Pre-existing heart disease
Renal or liver insufficiency
Pregnancy.
BMI > 35 kg/m2
Known allergy to study drugs 
 
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 
The difference in the mean propofol consumption (mg/kg/h) between the two groups.
 
At the end of procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of ‘patient discomfort’ defined as ≥1 of the following – bucking, retching, coughing or gagging
 
During the procedure 
Number of times rescue boluses of propofol is needed.  During the procedure 
Average heart rate and average mean arterial pressure.
 
During the procedure 
Number of significant episodes of desaturation (SpO2<95%)  During the procedure 
Time taken to achieve score of 3 on Ramsay sedation scale (RSS) after stopping infusions  At the end of procedure 
Incidence of emergence agitation on Richmond Agitation Sedation Scale (RASS)  At the end of procedure 
Endoscopist satisfaction on Likert scale (0-3)   At the end of procedure 
Patient satisfaction on Likert scale (0-3)   At 30 minute post procedure 
Patient Pain scores on Numerical rating Scale (NRS 0 -10)   At 30 minutes post procedure 
Time taken to achieve (≥9) on Modified Aldrete Score  In the post procedure period 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/06/2024 
Date of Study Completion (India) 16/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ajishaa@gmail.com].

  6. For how long will this data be available start date provided 01-06-2026 and end date provided 01-06-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Anaesthesia Protocol:

·         Patients posted for elective ERCP will be recruited based on inclusion criteria. Patients will be explained regarding the study and informed consent will be taken.

·         Adequate fasting as per standard ASA guidelines will be confirmed.

·         Demographic data including age, sex and BMI will be recorded.

·         All ERCPs will be performed by an endoscopist who has at least 5 year experience in performing the procedure.

·         A 20 G intravenous cannula will be secured.

·         2 puffs of 10 percent lignocaine spray will be sprayed over the posterior aspect of tongue, epiglottis and posterior pharyngeal wall in sitting position.

·         Patients will be premedicated with glycopyrrolate 0.2 mg IM 15 minutes before the procedure and fentanyl 1 mcg per kg IV just prior to sedation.

·         All patients will be placed in prone position. ASA standard monitors including ECG, Pulse oximetry and non-invasive blood pressure (NIBP) monitor will be attached and baseline SpO2, heart rate and mean arterial pressure (MAP) will be recorded. Oxygen will be delivered through nasal prongs at 4 L per min.

·         In group LP:

o   Patients will receive a loading dose of lignocaine (20 mg in 1ml dilution) 1.0 mg per kg IV and a bolus dose of propofol 1.0 mg per kg IV. More up-titration with 0.5mg per kg boluses of propofol will be done till a Ramsay Sedation Score of equal to or greater than 5 is achieved. Sedation will be maintained with 2 separate infusions of lignocaine 1.0 mg per kg per hr and propofol 5 per kg per hr.

·         In group KP:

o   Patients will receive ketamine (10mg in 1ml dilution) 0.5 mg per kg per hr IV followed by propofol 1 mg per kg IV. More up-titration with 0.5mg per kg will be done till Ramsay Sedation Score of equal to or greater than 5 is achieved. Sedation will be maintained with separate infusions of ketamine 0.5 mg per kg per hr IV and propofol 5 mg per kg per hr IV.

·         Any patient movement including bucking, retching, coughing or gagging will be noted as an event of patient discomfort and propofol 0.5 mg per kg IV will be given as rescue bolus.

·         All drug doses will be calculated and administered as per true body weight or ideal body weight whichever is lower.

·         All patients will receive a maintenance infusion of Ringer Lactate at 2 mg per kg per hr.

·         During the procedure, SpO2, heart rate and MAP will be measured at the time RSS of equal to or greater than 5 is achieved and thereafter, every 5 minutes, till the end of procedure. Increase in heart rate to greater than 25 percent from baseline will be treated with propofol 0.5 mg per kg IV bolus.

o   Any fall in MAP to greater than 20 percent of baseline will be treated with ephedrine 0.1 mg per kg IV. A fall of heart rate to less than 50 per min, with parallel fall in MAP greater than  20 percent will be treated with atropine 0.01 mg per kg IV.

·         All patients will be given paracetamol 15 mg per kg IV for analgesia.

·         At the end of procedure, all infusions will be stopped.

·         The endoscopist will be asked to rate his satisfaction on a Likert Scale

 

o   0 – Procedure completed without any difficulty

o   1 – Procedure possible with mild difficulty

o   2 -- Procedure possible with major difficulty

o   3 – Not possible to perform procedure.

 

·         Upon achieving a score of 3 on RSS, patient will be shifted to the recovery room. The time of arrival in recovery room will be t0.

·         At 30 min post procedure, patients will be enquired about sore throat (pain or irritation, independent of speaking or swallowing) and asked to subjectively grade each of these symptoms on a Likert scale

o   0 – none

o   1 – mild (occasional)

o   2 – moderate (constant but bearable)

o   3 – severe (unbearable)

 

·         The discharge criteria from PACU will be based on the Modified Aldrete Score which will be assessed every 15 minutes till a score equal to or greater than 9 is achieved.

 
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