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CTRI Number  CTRI/2021/10/037382 [Registered on: 20/10/2021] Trial Registered Prospectively
Last Modified On: 18/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   TO STUDY THE EFFECT OF NEUROMUSCULAR TRANSMISSION MONITORING ON THE REQUIREMENT OF MUSCLE RELAXANT AND RECOVERY IN PATIENTS UNDERGOING GENERAL ANAESTHESIA 
Scientific Title of Study   TO STUDY THE EFFECT OF NEUROMUSCULAR TRANSMISSION MONITORING (TOF) ON THE REQUIREMENT OF MUSCLE RELAXANT AND RECOVERY IN PATIENTS UNDERGOING GENERAL ANAESTHESIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aparna Bagle 
Designation  Professor  
Affiliation  Professor department of anesthesiology 
Address  Department of Anaesthesia,, Dr D Y Patil Medical College and Hospital
Department of Anaesthesia,, Dr D Y Patil Medical College and Hospital
Pune
MAHARASHTRA
411018
India 
Phone  9834430811  
Fax    
Email  draparnabagle@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Preeti Raj 
Designation  Junior resident 
Affiliation  Dr D Y Patil Hospital and Research Centre 
Address  Department of anaesthesia,Dr D Y Patil Hospital and research centre, Pimpri
Department of anaesthesia,Dr D Y Patil Hospital and research centre, Pimpri
Pune
MAHARASHTRA
411018
India 
Phone  9810749754  
Fax    
Email  hipreeti20@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Preeti Raj 
Designation  Junior resident 
Affiliation  Dr D Y Patil Hospital and Research Centre 
Address  Department of anaesthesia,Dr D Y Patil Hospital and research centre, Pimpri
Department of anaesthesia,Dr D Y Patil Hospital and research centre, Pimpri
Pune
MAHARASHTRA
411018
India 
Phone  9810749754  
Fax    
Email  hipreeti20@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil Hospital and Research Centre, Pune 
 
Primary Sponsor  
Name  Dr D Y Patil Hospital and Research Centre 
Address  Sant Tukaram Nagar, Pimpri, Pune, Maharashtra- 411018 
Type of Sponsor  Research institution and hospital 
 
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 Preeti  Department of Anaesthesia, Dr. D Y Patil Medical College and Research Centre  Dr D Y Patil Hospital and research centre, Pimpri, Pune
Pune
MAHARASHTRA 
9810749754

hipreeti20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Dr D Y Patil Vidyapeeth, Pune  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  TOF Monitor  Time from the last dose of injection Vecuronium till recovery TOF ratio to 0.9 in Group A 
Comparator Agent  Without TOF Monitor  Time from the last dose of injection Vecuronium return of spontaneous respiration in Group B will be noted.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing general anaesthesia
Patients under ASA I and II
Age between 18 to 60 years.
Patients willing to sign the informed consent voluntarily
 
 
ExclusionCriteria 
Details  Pregnant females
Patients with cognitive and mental disorders
Patients with any neuromuscular disorders
ASA III and above
Patients with anticipated difficult intubation
Surgery duration of more than 4 hours
Surgeries in which either major blood loss/fluid shifts expected or occurs
Surgeries of Head and neck
Planned for awake extubations
Patient in need of postsurgery intensive care admission
Patient with body mass index >35 kg/m2
Patient with hepatic disease (liver enzyme value >50% normal value)
Patient with renal insufficiency (serum creatinine>1.8 mg/dL)
Patient with history of consumption of drugs known to affect neuromuscular transmission
Any contraindications to neostigmine and/or atropine sulphate
Patient with history of hypersensitivity or allergic to anaesthetic agent given
Difficulty accessing the TOF measuring device in the ulnar nerve. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the effect of neuromuscular transmission monitoring (train of four) on the requirement of muscle relaxant and recovery in patients undergoing general anaesthesia  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1)To determine the total dose of muscle relaxant requirement for intubation
2)To determine the dose of intra-operative muscle relaxant requirement per hour
3)To observe the time required for the patient to respond to verbal commands after stopping of all the anaesthesia maintenance drugs
4)To observe the time required for extubation
5)To observe for any postoperative residual paralysis 
5 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   21/10/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [hipreeti20@gmail.com].

  6. For how long will this data be available start date provided 01-03-2022 and end date provided 31-12-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

A wide range of surgeries are done under general anaesthesia, and the maintenance of muscle relaxation is important in facilitating surgical procedures.Neuromuscular blocking agents (NMBA), which are used in facilitation of intubation for general anaesthesia and maintenance of muscle relaxation during the surgery, pose risk of residual paralysis. Residual paralysis (RP) after neuromuscular blockade (NMB) in the recovery room occurs in around 56.5% of patients, and it can increase the incidence of airway obstruction, hypoxaemia and postoperative pulmonary complications. 

Neuromuscular Transmission monitoring (NMTM) is a means to determine the degree of NMB by stimulating a motor nerve with electric current and observe the degree of contraction of the muscles innervated by that nerve. It is used to evaluate the effect of  NMBA. The muscle response after stimulation of its corresponding motor nerve is assessed. The most frequently assessed nerve-muscle unit is the ulnar nerve and the adductor pollicis muscle.The muscle response can be evaluated either qualitatively or quantitatively. Qualitative (subjective) assessment is done with a peripheral nerve stimulator, where the observer evaluates the muscle response either tactically or visually. Quantitative assessment is done with the monitor and the response is objectively measured and displayed on a screen.Mechanomyography, electromyography and acceleromyography are such muscle response recording methods in quantitative monitoring. The types of stimuli used in NMTM are single stimulus, train of four (TOF) and post tetanic count (PTC).The TOF technique has remained the most useful method for assessing neuromuscular function for more than 40 years because it is simple and easy to assess. It is based on the observation that increased stimulation frequency produces muscle fatigue or fade. The proportion that results from dividing the fourth by the first evoked twitch (T4/T1) is the train-of-four ratio (TOFR). TOF has been recommended in clinical practice because it is the test that measures neuromuscular function and is capable of providing information even when no prior value has been obtained. TOF count is an excellent guide considering that it reports not only the degree of neuromuscular block but also the state of recovery from it. In most of the centers, the subjective assessment of recovery from the effect of a NMBA is done by observing eye‑opening, tongue protrusion, head lift and sustained hand grip for more than 5 seconds. 

Our study would like to evaluate the efficiency of the use of objective neuromuscular transmission monitoring by TOF when compared to subjective assessment in guiding the frequency of repeating the NMBAs during surgery and in assessing adequacy of reversal from NMBA at the time of recovery from generalanaesthesia and in incidences of postoperative residual paralysis.

 
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