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
|
|
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
|
|
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 efï¬ciency of facemask ventilation in patients difï¬cult 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. |