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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  
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 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  18 to 60 years either sex ASA I and II,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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