CTRI Number |
CTRI/2016/10/007419 [Registered on: 31/10/2016] Trial Registered Prospectively |
Last Modified On: |
12/02/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Use of neuromuscular monitor to assess intubating conditions |
Scientific Title of Study
|
EVALUATION OF INTUBATING CONDITIONS WITH ROCURONIUM 0.6 mg/Kg USING TRAIN OF FOUR STIMULATION IN ELECTIVE SURGERY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Deepa Rani |
Designation |
Post Graduate Student |
Affiliation |
Lady Hardinge Medical College |
Address |
Department of Anaesthesiology
Lady Hardinge Medical College
SSK Hospital
New Delhi DELHI 110001 India |
Phone |
8826599684 |
Fax |
|
Email |
deeparani10220@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Nishant Kumar |
Designation |
Associate Professor |
Affiliation |
Lady Hardinge Medical College |
Address |
Department of Anaesthesiology
Lady Hardinge Medical College
SSK Hospital
New Delhi DELHI 110001 India |
Phone |
9811934659 |
Fax |
|
Email |
kumarnishant@yahoo.co.uk |
|
Details of Contact Person Public Query
|
Name |
Dr Nishant Kumar |
Designation |
Associate Professor |
Affiliation |
Lady Hardinge Medical College |
Address |
Department of Anaesthesiology
Lady Hardinge Medical College
SSK Hospital
New Delhi DELHI 110001 India |
Phone |
9811934659 |
Fax |
|
Email |
kumarnishant@yahoo.co.uk |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology
Lady Hardinge Medical College
SSK Hospital New Delhi |
|
Primary Sponsor
|
Name |
Lady Hardinge Medical College |
Address |
Department of Anaesthesiology
Lady Hardinge Medical College
SSK Hospital |
Type of Sponsor |
Government 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 Deepa Rani |
Main Operation theatre |
Department of Anaesthesiology
Lady Hardinge Medical College
SSK Hospital New Delhi DELHI |
8826599684
deeparani10220@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
18 to 60 years
either sex
ASA I and II, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Age 18 to 60 yrs of either sex
2.ASA physical status I and II
3.Planned for elective surgery under general anaesthesia receiving rocuronium 0.6 mg/Kg for endotracheal intubation
|
|
ExclusionCriteria |
Details |
1.Patient refusal to participate in the study
2.Patients with history of neuromuscular disease
3.Patients having anticipated difficult airway
4.Patients with BMI <20 and >30
5.Patients unable to converse in Hindi or English
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Number of patients having excellent intubating conditions with rocuronium 0.6mg/Kg |
After endotracheal intubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
a)Mean time to achieve T1 or T0
b)Intubating conditions at T1 or T0
c)Influence of anaesthetic agents on intubating conditions
d)Number of patients presenting with sore throat immediate and 24 hours post extubation at T1 or T0
|
a-c) after intubation
d)after intubation and 24 hours postoperative |
|
Target Sample Size
|
Total Sample Size="250" Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
07/11/2016 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Results will be published in a scientific journal |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Neuromuscular
blockers (NMBs) are widely used in anaesthesia practice during endotracheal
intubation. The degree of neuromuscular block is usually evaluated by clinical
criteria. But the recommendation for application of neuromuscular monitoring to
patients receiving NMBs is based on two important issues: first, on the
variable individual response to muscle relaxants and second because of the
narrow therapeutic window. Adequate muscle relaxation for intubation corresponds to a narrow range
of 90 to 95% receptor occupancy.1 Inadequate muscle relaxation
during intubation can lead to difficulty in securing the airway or multiple
attempts leading to laryngeal morbidity like postoperative hoarseness (4-42%)
and vocal cord injury.2
Rocuronium
is one of the most commonly used non depolarising muscle relaxant for
intubation of the trachea. It has been postulated that laryngeal muscles being
resistant to the effects of neuromuscular blocking agents,3 require
at least twice the ED95 dose.4
As
it is difficult to quantify the relaxation of the laryngeal muscles, therefore
surrogates such as Adductor pollicis longus (APL), orbicularis oculi (OO),
corrugator supercilii (CS)5 and even flexor hallucis brevis (FHB)6
have been utilised, though APL is the preferred site. Neuromuscular transmission
can be monitored by various methods like single twitch (ST), double burst
stimulation (DBS) and train of four (TOF). Although good clinical research
practice (GCRP) states that either ST or TOF can be used as a guide for
intubation, TOF is preferable because it is more sensitive to lesser degree of
receptor occupancy than single twitch.1 Observation of evoked TOF
responses after a dose of non depolarising
muscle relaxant allows prediction of onset time of paralysis of
laryngeal muscles in individual
patients.
In
the absence of availability of NMT monitors, timed intubation has been
practiced. However, patient factors1 such as age, gender,7
medical condition (ASA physical status), body weight affect the
pharmacokinetics and pharmacodynamics of the drug.
On
reviewing the literature, we found that although, clinically acceptable
conditions have been obtained with rocuronium 0.6mg/kg in 90 seconds, there
have not been many studies to quantify the proportion of patients having
excellent conditions and time required thereof for a standard observable
endpoint i.e, disappearance of either three (T1) or all twitches (T0) after a
TOF stimulus. The literature does not indicate which endpoint provides the best
intubating conditions.
Therefore
there is a need to ascertain the percentage of healthy routine patients
achieving excellent intubating conditions and the time taken to achieve these
with rocuronium 0.6mg/Kg using defined monitor i.e, TOF stimulation and associated
post operative sore throat if any.
|