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CTRI Number  CTRI/2020/01/022910 [Registered on: 22/01/2020] Trial Registered Prospectively
Last Modified On: 17/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Validity of practice of checking facemask ventilation before neuromuscular blockade 
Scientific Title of Study   Efficiency of Face Mask Ventilation before and after Neuromuscular Blockade : A Randomised Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Supriya Kumar 
Designation  MD Trainee 1st year  
Affiliation  IGIMS, Patna 
Address  Department of Anaesthesiology, IGIMS, Patna

Patna
BIHAR
800014
India 
Phone  8376947896  
Fax    
Email  supriyakumar08@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mumtaz Hussain 
Designation  Associate Professor 
Affiliation  IGIMS, Patna 
Address  Department of Anaesthesiology, IGIMS, Patna

Patna
BIHAR
800014
India 
Phone  9473376853  
Fax    
Email  drhussain72@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Supriya Kumar 
Designation  MD Trainee 1st year  
Affiliation  IGIMS, Patna 
Address  Department of Anaesthesia, IGIMS, Patna

Patna
BIHAR
800014
India 
Phone  8376947896  
Fax    
Email  supriyakumar08@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, IGIMS, Patna 
 
Primary Sponsor  
Name  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anaesthesiology, IGIMS, Patna, Bihar 800014 
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 
Supriya Kumar  Indira Gandhi Institute of Medical Sciences  Department of Anaesthesiology, IGIMS, Sheikhpura,Patna
Patna
BIHAR 
8376947896

supriyakumar08@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  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Effect of face mask ventilation before and after drug administration   timely monitoring at 30,60,90 seconds after giving drug  
Comparator Agent  not applicable  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1 Patients of ASA physical status 1 and 2
2 Patient with airway of Mallampati Grade I and II.
3 Patient willing to participate.
 
 
ExclusionCriteria 
Details  Exclusion criteria :
1 Patient’s refusal to participate.
2 Patients with pregnancy, morbid obesity, full stomach and emergency surgery.
3 Patients with ASA Physical status III and above.
4 Patient with suspected difficult airway and Mallampatti Grade III and IV.
5 Patients with known predictors of difficult airway such as BMI>35 kg/m2, history of neck mass/ irradiation, cervical trauma, restricted neck movement, OSA, limitation in mouth opening or jaw protrusion
6 Patients with allergy to study drug, neuromuscular disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be the average of mask expiratory tidal volume measured at 30,60,90 seconds after apnea onset. The secondary outcome will be the time from apnea to tracheal intubation  30,60,90 seconds after apnea onset.
 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome will be the time from apnea to tracheal intubation  onset of apnea to tracheal intubation  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 1 
Date of First Enrollment (India)   24/01/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1 Se-Hee Min, MD, Hyunjae Im, MD, Bo Rim Kim, MD, Susie Yoon, MD, Jae-Hyon Bahk, MD, PhD, and Jeong-Hwa Seo, MD, PhD ANESTHESIA & ANALGESIA August 2019 • Volume 129 • Number 2 2 S. Soltesz,1 P. Alm,1 A. Mathes,2 M. Hellmich3 and J. Hinkelbein2 The effect of neuromuscular blockade on the efficiency of facemask ventilation in patients difficult to facemask ventilate: a prospective trial (Anaesthesia 2017, 72, 1484–149).  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A very important aspect of inducing a patient under general anaesthesia is securing an airway for intraoperative ventilation. Expert airway management is an essential skill in anaesthetic practice for allowing oxygenation, ventilation and anaesthetic gas delivery.[1] Tracheal intubation remains the most common approach to airway management.

The general sequence of induction of anaesthesia is administration of an analgesic and IV anaesthetic agent after which facemask ventilation is tested and lastly a neuromuscular blocking agent is administered. Because of possible development of airway catastrophes, muscle relaxants have long been recommended to be administered after confirming adequate face mask ventilation, without any scientific validation of this principal.

The rationale for delaying administration of muscle relaxant is the belief that if face mask ventilation in an anaesthetised non-paralysed patient is ineffective, the patient can be reversed and an alternative airway management can be considered. Life threatening hypoxemia can therefore, theoretically, be averted.[2]

 In 2008, Calder and Yentis argued against the practice of checking facemask ventilation. They questioned the validity and safety of this practice. The argument against the practice was that if neuromuscular blocking agent is delayed on the pretext of assessing facemask ventilation, the anaesthetist has already lightened the plane of anaesthesia for the said patient and caused difficult ventilation. [4]

If facemask ventilation is difficult or impossible in an anaesthetised non-paralysed patient there are two courses of action that may be followed. First course could be to withhold all anaesthetic agents and allow the plane of anaesthesia to become superficial causing the spontaneous return of respiration. The second approach is to administer a neuromuscular blocking agent (Suxamethonium or rocuronium) to facilitate intubation and ventilate the patient, but, if even intubation fails, patient can be reversed and spontaneous respiration awaited. Both approaches seem logical as long as spontaneous respiration is achieved before severe hypoxemia develops. The limitation here, however, is that the pre-existing anatomic problems which were causing difficult facemask ventilation in the first place have been worsened with administration of anaesthetic agents which led to collapse of the upper airways. Therefore, the chances of achieving spontaneous respiration in an apnoeic, anaesthetised patient before severe hypoxemia develops is minute. [4]

At this crossroads the rationale of the practice of delayed administration of neuromuscular blocking agent becomes questionable.

 

 

Investigators have reported either no effect or improvements in mask ventilation difficulty scores and exhaled volumes after neuromuscular blocking drugs have been administered. 

This study uses cis-atracurium as the non-depolarising neuromuscular blocking agent. It is four to five times as potent as atracurium and does not cause histamine release. It provides intubating conditions in a dose of 0.10 - 0.15mg/kg within 2 minutes and results in blockade of intermediate duration.

 
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