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
|
|
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). |