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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  
NA 
 
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  
Name  Address 
nil   
 
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  
Status 
Not Applicable 
 
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.

 

 

 
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