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CTRI Number  CTRI/2023/02/049888 [Registered on: 20/02/2023] Trial Registered Prospectively
Last Modified On: 31/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Surgical/Anesthesia
Process of Care Changes 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To determine the advantage of giving a smaller dose of the muscle relaxant drug atracurium prior to giving total dose by measuring the amount of neuromuscular receptors blocked using TOF monitor  
Scientific Title of Study   QUANTITATIVE ASSESSMENT OF NEUROMUSCULAR BLOCKADE USING PRIMING PRINCIPLE WITH ATRACURIUM AND TRAIN OF FOUR MONITORING: A PROSPECTIVE RANDOMISED DOUBLE-BLINDED STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHEETHAL BABY SCARIA 
Designation  POST GRADUATE RESIDENT 
Affiliation  ST JOHNS MEDICAL COLLEGE HOSPITAL 
Address  DR SHEETHAL BABY SCARIA, POST GRADUATE RESIDENT, DEPARTMENT OF ANAESTHESIOLOGY, ROOM NO 18, STJOHNS MEDICAL COLLEGE HOSPITAL
DR SHEETHAL BABY SCARIA POST GRADUATE RESIDENT, DEPARTMENT OF ANAESTHESIA, ROOM NO 18 ,ST JOHNS MEDICAL COLLEGE HOSPITAL
Bangalore
KARNATAKA
560034
India 
Phone  9895007091  
Fax    
Email  DRSHEETHALBABYSCARIA@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  SAVITHA KS  
Designation  PROFESSOR 
Affiliation  ST JOHNS MEDICAL COLLEGE HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY ST JOHNS MEDICAL COLLEGE HOSPITAL BANGALORE

Bangalore
KARNATAKA
560034
India 
Phone  9844638121  
Fax    
Email  DRSAVITHA_KS@YAHOO.COM  
 
Details of Contact Person
Public Query
 
Name  SHEETHAL BABY SCARIA 
Designation  POST GRADUATE RESIDENT 
Affiliation  ST JOHNS MEDICAL COLLEGE HOSPITAL 
Address  DR SHEETHAL BABY SCARIA, POST GRADUATE RESIDENT, DEPARTMENT OF ANAESTHESIA, ROOM NO 18, ST JOHNS MEDICAL COLLEGE HOSPITAL
DR SHEETHAL BABY SCARIA POST GRADUATE RESIDENT, DEPARTMENT OF ANAESTHESIA, ROOM NO 18, ST JOHNS MEDICAL COLLEGE HOSPITAL
Bangalore
KARNATAKA
560034
India 
Phone  9895007091  
Fax    
Email  DRSHEETHALBABYSCARIA@GMAIL.COM  
 
Source of Monetary or Material Support  
ST JOHNS MEDICAL COLLEGE HOSPITAL, JOHN NAGAR, SARJAPUR ROAD, BANGALORE 560034 
 
Primary Sponsor  
Name  SHEETHAL BABY SCARIA 
Address  JUNIOR RESIDENT , DEPARTMENT OF ANAESTHESIA, ST JOHNS MEDICAL COLLEGE, JOHN NAGAR, SARJAPUR ROAD, KORAMANGALA, BANGALORE -560034  
Type of Sponsor  Other [SELF- FUNDED] 
 
Details of Secondary Sponsor  
Name  Address 
SAVITHA KS  PROFESSOR, DEPARTMENT OF ANAESTHESIA ST JOHNS MEDICAL COLLEGE HOSPITAL BANGALORE -560034  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SHEETHAL BABY SCARIA  ST JOHNS MEDICAL COLLEGE AND HOSPITAL  ROOM NO.9 2nd FLOOR OPERATION THEATRE COMPLEX,ST JOHNS MEDICAL COLLEGE HOSPITAL, JOHN NAGAR, SARJAPUR ROAD, KORAMANGALA , BANGALORE 560034
Bangalore
KARNATAKA 
9895007091

DRSHEETHALBABYSCARIA@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, ST JOHNS MEDICAL COLLEGE & HOSPITAL  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  Priming with neuromuscular agent ATRACURIUM  Assessing the extent of neuromuscular blockade by giving a priming dose -atracurium at 0.05mg/kg from calculated total intubating dose of 0.5mg/kg, intravenously—of neuromuscular blocking agent atracurium at the end of 3 minutes 
Comparator Agent  priming with normal saline  priming with normal saline is done as part of blinding. It will be followed by full dose of neuromuscular blocking agent atracurium and the extent of neuromuscular blockade is assessed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  1.Patients undergoing elective surgery under General anesthesia requiring endotracheal intubation.
2. Patients aged between 18 and 59 years of either sex
3. Patients with American Society of Anesthesiologists (ASA) class I
4.Patients with BMI 18 -30kg/m 2 
 
ExclusionCriteria 
Details  1. Surgeries involving anticipated risk of aspiration
2. Patients with musculoskeletal disorders
3. Patients with anticipated difficult airway
4. Pregnant women.
5. Patients on aminoglycoside antibiotics 
 
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 compare the percentage of the neuromuscular receptors blocked at 3 minutes with and
without priming in ASA I patients, undergoing elective surgeries under general anesthesia using TOF monitor 
3 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
intubating conditions using Cooper scoring system  at 0 minutes of intubation 
time taken for zero twitch after bolus intubating dose of injection atracurium   time taken for zero twitch in minutes 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/03/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet from this trial 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Neuromuscular blocking agents are administered to provide excellent intubating conditions to
minimize airway trauma. Muscle relaxants are broadly classified into depolarizing and non-
depolarizing muscle relaxants. In anaesthesiology, non-depolarizing neuromuscular blocking agents
are used routinely for endotracheal intubation. In our study atracurium a steroidal non- depolarizing
neuromuscular blocking agent will be used.

To provide rapid and profound intubating conditions various techniques like combination of
muscle relaxants, timing principle, high dose non-depolarizing neuromuscular blocker and priming
principle are used. Priming principle is a technique in which a small dose (10% to 30% of intubation
dose) of non-depolarizing neuromuscular blocking agent is administered 3-5 minutes prior to
administration of large intubating dose to produce relatively rapid and profound neuromuscular
receptors blockade to ensure adequate intubating conditions for endotracheal
intubation. This technique is preferred in rapid sequence intubation and in patients in whom non-
depolarizing muscle relaxant succinylcholine is contraindicated

Neuromuscular function is evaluated using qualitative and quantitative clinical tests. Qualitative
evaluation employs peripheral nerve stimulators (PNSs) and assesses visually or tactilely the
response of the stimulated muscle. A standard PNS can provide several patterns of nerve
stimulation such as train of four (TOF), double-burst (DBS), tetanic and post-tetanic count (PTC)
or degree of fade. The TOF stimulation pattern was introduced aiming at a tool providing clinically
reliable information through all phases of neuromuscular blockade with simple peripheral nerve
stimulator. Commonly stimulated nerve is ulnar nerve innervating adductor pollicis muscle.

The aim of our study is to evaluate the percentage of Neuromuscular receptors blocked, time taken
for zero twitch and intubating condition with and without priming with atracurium, in adult patients
undergoing elective surgery under general anaesthesia.In the literature, there are studies assessing
intubating conditions, hemodynamic stability, presence of post-operative sore throat & hoarseness
and, post-operative residual curarisation using TOF monitoring. However, there are not many
studies quantifying the percentage of neuromuscular receptors blocked with and without priming
principle using TOF monitor.
We hypothesize that 80% of the neuromuscular receptors will be blocked in 3 minutes following
priming with Injection Atracurium 0.05 mg/kg (1/10th of intubating dose).
 
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