CTRI Number |
CTRI/2018/02/011887 [Registered on: 13/02/2018] Trial Registered Retrospectively |
Last Modified On: |
09/02/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Follow Up Study |
Study Design |
Single Arm Study |
Public Title of Study
|
is neuromuscular monitoring mandatory before extubation |
Scientific Title of Study
|
CORRELATION oF CLINICAL SIGNS WITHH NEUROMUSCULAR
MONITORING (TOF) DURING REVERSAL OF NEUROMUSCULAR BLOCKADE -AN
OBSERVATIONAL STUDY
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rani P |
Designation |
Associate Professor |
Affiliation |
Mahatma Gandhi Medical College and Research Institute |
Address |
Department of anaesthesiology,
Mahatma Gandhi Medical College and Research Institute,
Pillaiyarkuppam, Pondicherry- Cuddalore road, Puducherry Pillaiyarkuppam, pondicherry- cuddalore road, Puducherry Pondicherry PONDICHERRY 607403 India |
Phone |
9443116908 |
Fax |
|
Email |
anaesrani@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rani P |
Designation |
Associate Profesor |
Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE, PUDUCHERRY |
Address |
Mahatma Gandhi Medical College and Research Institute
Pillaiyarkuppam, Pondicherry- Cuddalore road, Puducherry Pillaiyarkuppam, Pondicherry- Cuddalore road, Puducherry Pondicherry PONDICHERRY 605007 India |
Phone |
9443116908 |
Fax |
|
Email |
anaesrani@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrGovind shaji |
Designation |
postgraduate |
Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE, |
Address |
Mahatma Gandhi Medical College and Research Institute
Pillaiyarkuppam, pondicherry- cuddalore road, Puducherry Pillaiyarkuppam, Pondicherry- Cuddalore road, Puducherry Pondicherry PONDICHERRY 605007 India |
Phone |
8547970798 |
Fax |
|
Email |
govind.shaji14@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
mahatma gandhi medical college and research institute |
Address |
pillaiyarkuppam, puducherry- cuddalore road, puducherry |
Type of Sponsor |
Private 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 |
DrRani P |
Mahatma Gandhi Medical College and Research Institute |
Pillaiyarkuppam
Pondicherry-Cuddalore road
Puducherry Pondicherry PONDICHERRY |
9443116908 9443116908 anaesrani@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Human Ethics Committee(IHEC) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
undergoing general anesthesia with endotracheal intubation with controlled ventilation, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
15.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
ASA I ,and II patients
Age 15-70 years
Patients undergoing elective procedure under general anaesthesia with endotracheal intubation and controlled ventilation.
|
|
ExclusionCriteria |
Details |
Patients having neuromuscular disorder, hepatic or renal dysfunction,
Difficult airway
Patients who are under medications that influences the action of neuromuscular blockade
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
TOF monitoring will be done during reversal administration,extubation and 15 minutes interval in post operative period
|
TOF monitoring will be done during reversal administration,extubation and 15 minutes interval in post operative period
|
|
Secondary Outcome
|
Outcome |
TimePoints |
nil |
nil |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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 2 |
Date of First Enrollment (India)
|
15/02/2017 |
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="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
NA |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Neuromuscular
blocking agents are used to improve conditions for tracheal intubation, to
provide immobility during surgery, and to facilitate mechanical ventilation.It is
also essential to make sure that the effects of neuromuscular blocking drugs
have worn off or are reversed before the patient is shifted to post anaesthetic
care unit(PACU). With
intermediate acting agents, the incidence of residual paralysis remains high
with an overall 16% incidence has been reported without neuromuscular
monitoring compared to 3% in AMG monitored patients.(1)The
threshold for complete neuromuscular recovery is a train-of-four ratio of 0.9,
instead of the traditional 0.7. Recent
studies have demonstrated that low dose neostigmine 20mcg/kg
is adequate to reverse the shallow neuromuscular blocking effects (TOFR 0.4)of vecuoronium (2), atracurium (3), rocuronium and cisatracurium(4).When neostigmine
40mcg/kg was given to reverse shallow
neuromuscular blockade produced by vecuronium they observed a drop in train of four ratio(TOFR) in the recovery
period.(2) Anticholinesterases, if given when neuromuscular block is absent,
may produce evidence of neuromuscular dysfunction. In day to
day practise routine neuromuscular monitoring is not done and standard dose of neostigmine (40- 60
µg/kg )is given as reversal when patient has
spontaneous attempts of breathing as a clinical sign of early stage of recovery
from neuromuscular blocking effects.We like
to observe and correlate the clinical signs of neuromuscular recovery with
neuromuscular monitoring (TOF). (spontaneous breathing during reversal) and (sustained head lift for
5secs during extubation ) and
(respiratory rate in early postoperative period ).ASA I and II patients, with age 18-60 years and undergoing elective procedure
under general anaesthesia with
endotracheal intubation and controlled ventilation
will be enrolled in the study. Patients having neuromuscular disorder, hepatic or renal dysfunction, Difficult airway and Patients who are under medications that
influences the action of neuromuscular blockade are excluded from the study. After obtaining ethical committee approval, surgical
patients posted for surgery under general anaesthesia with endotracheal tube
intubation and controlled ventilation will be recruited for the study.
Pre-anesthetic check will be done and the patients those satisfying the
inclusion and exclusion criteria will be enrolled in the study by continuous
sampling. written informed consent will be obtained . patients will be kept
nil per oral for 8hours. patients will be premedicated with tab. ranitidine
150mg and tab. alprazolam 0.25mg night before and morning of surgery. After
transferring the patient into the operation room monitors ( electrocardiogram(ECG), noninvaive
bloodpressure(NIBP), pulseoximeter(SPO2) will be connected and baseline
readings will be noted. .Intravenous cannulation will be done with a 18 G
cannula and Ringer Lactate infusion will be started . Surface electrodes will
be placed over the course of the ulnar nerve , just proximal to the wrist
crease and neuromuscular monitor will be connected. premedication with inj. morphine
(0.1mg/kg ),inj.midazolam 1mgwill be done .TOF stimulation will be given with
5 MA current and response will be assessed.
Patient will be preoxygenated with 100% oxygen for three minutes and
induced with Propofol(2-3mg/kg). At
this stage Acceleromyography will be calibrated using the preprogrammed TOF-Watch calibration mode applying supramaximal
stimulation current. Supramaximal current is the current above which there is
no significant increase in electromyographic amplitude. When the TOF-Watch is
switched on, it automatically sets the current to 60mA and amplitude to 100%.
The current is then reduced in decrements of 5 mA till response of ≤ 90% is
reached. Then 10% will be added to next higher value and this current is taken
as supramaximal current. After
stable base line recording of the TOF response, vecuronium bromide 0.1mg/kg IV will be administered to facilitate tracheal
intubation. During surgery, vecuronium bromide bolus doses will be given to
maintain TOF count 2. Anaesthesia was maintained with 40% oxygen in nitrous
oxide (600ml total flow) along with Isoflurane to maintain a MAC of 1. End
tidal concentration of CO2 to be maintained between 32
and 36 mmHg and central body temperature between 35-37 degree celsius throughout the surgical procedure. Ten minutes
before expected time of end of surgery isoflurane will be stopped . Once the
patient starts to breath spontaneously TOF will be monitored and when patient
has regular breathing TOF will be assessed and they will be given reversal
with glycopyrrolate 0.01mg/kg and neostigmine
50mcg/kg. Patient will be extubated after thorough oral suctioning and TOFR will
be monitored and monitoring will be done every 10 minutes for one hour in the
post operative period.
|