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CTRI Number  CTRI/2023/02/050085 [Registered on: 26/02/2023] Trial Registered Prospectively
Last Modified On: 23/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Sugammadex and Neostigmine for reversal of neuromuscular blockade in children undergoing surgery with general anaesthesia 
Scientific Title of Study   Comparison of Sugammadex and Neostigmine for reversal of Vecuronium induced neuromuscular blockade in paediatric patients: A prospective randomised 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 Aarti Agarwal 
Designation  Additional Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Dept. of Anaesthesiology Sanjay Gandhi Post Graduate Institute of Medical Sciences Lucknow
SGPGIMS Raibareilly Road, Lucknow
Lucknow
UTTAR PRADESH
226014
India 
Phone  9918246222  
Fax    
Email  aarti_agarwal000@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aarti Agarwal 
Designation  Additional Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Dept. of Anaesthesiology Sanjay Gandhi Post Graduate Institute of Medical Sciences Lucknow
SGPGIMS Raibareilly Road, Lucknow

UTTAR PRADESH
226014
India 
Phone  9918246222  
Fax    
Email  aarti_agarwal000@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Dr Aarti Agarwal 
Designation  Additional Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Dept. of Anaesthesiology Sanjay Gandhi Post Graduate Institute of Medical Sciences Lucknow
SGPGIMS Raibareilly Road, Lucknow

UTTAR PRADESH
226014
India 
Phone  9918246222  
Fax    
Email  aarti_agarwal000@yahoo.co.uk  
 
Source of Monetary or Material Support  
Intramural grant from SGPGIMS Lucknow 
 
Primary Sponsor  
Name  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Research Cell Administrative Block Sanjay Gandhi Post Graduate Institute of Medical Sciences Lucknow 
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 Aarti Agarwal  Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow  Dept of Anaesthesiology A Block, First Floor Main Hospital building, Sanjay Gandhi Post Graduate Institute of Medical Sciences Raibareilly Road Lucknow, UP, India
Lucknow
UTTAR PRADESH 
9918246222

aarti_agarwal000@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute 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 
Comparator Agent  Injection neostigmine and glycopyrrolate / atropine  At the end of surgery, Single dose of injection neostigmine 50 mcg/kg plus glycopyrrolate 10 mcg/kg or atropine 20 mcg/kg. Intravenously 
Intervention  Injection Sugammadex  At the end of surgery, Single dose of 2mg/kg, Intravenously.  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1) Children of 2 years of age to 12 years of age.
2) ASA Physical status 1,2 and 3
3) Those requiring general anaesthesia with endotracheal intubation for their elective surgical procedure.
 
 
ExclusionCriteria 
Details  1) ASA physical status 4
2) Children with known or suspected co-existing neuromuscular disease, bleeding disorders, or kidney dysfunction
3) Patient shifted on ventilator to PACU
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary Aims
1. To compare the time from the start of administration of neostigmine or sugammadex until a train-of-four (TOF) ratio of 0.9 (1st twitch paralysis) is recovered.
2. To determine the time between the start of antagonist administration (either neostigmine or sugammadex) and the recovery of a TOF ratio of 1.0.
 
At 15 minutes after recovery from neuromuscular blockade 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Aims
1. To find out the incidence of postoperative recurrence of neuromuscular blockade, which is defined either as a decrease in the TOF ratio to below 0.9 after full recovery, or as a deterioration in the clinical signs of recovery from the block.
2. To find out the incidence of other adverse effects like bradycardia, tachycardia, laryngospasm, bronchospasm and increased respiratory secretions.
 
Upto 1 hour after achieving TOF ratio of 1.0 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   01/03/2023 
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   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Neuromuscular blocking agents are used to facilitate endotracheal intubation and to provide surgical muscle relaxation in patients receiving general anaesthesia for various surgical interventions. Cholinesterase inhibitors are traditionally used for reversal of neuromuscular blockade (NMB) at the end of surgery during emergence from anaesthesia. Neostigmine is the most potent and selective cholinesterase inhibitor drug used for reversing the residual muscle relaxation.1,2 These cholinesterase inhibitor agents have various systemic side effects, because they are not selective to nicotinic receptors and also stimulate the muscarinic receptors, thereby producing various  serious adverse effects such as : Bradycardia, QT prolongation, bronchoconstriction, hypersalivation and increased motility.2 Anticholinergic agents such as atropine or glycopyrrolate, are administered to the patients  to prevent muscarinic side effects which have their own set of side effects such as tachycardia, hypertension, mucosal dryness of respiratory tract etc.3 

Sugammadex is a newly introduced agent in India which can be used  an alternative to Neostigmine as reversal agent at the end of surgery when patient is emerging from anaesthesia. It is said that post operative residual curarization and the muscarinic side effects are not encountered when using sugammadex.  Sugammadex is said to be selective for reversal of neuromuscular blockade of rocuronium and vecuronium.4-6 Postoperative residual neuromuscular blockade increases the risk of postoperative pulmonary diseases and respiratory complications, such as pulmonary atelectasis, decreased oxygen saturation and upper airway obstruction, which may result in reintubation in the ICU and prolong the patient’s length of stay.7

Paediatric patients are especially susceptible to respiratory complications produced at the time of emergence from anaesthesia especially because of usage of neuromuscular blocking agents and because of drugs used for reversal of them. Various physiological factors contribute for this increased susceptibility like; lesser physiological reserve, smaller diameter of trachea, rudimentary neuromuscular junction, the variability of fibrin fibers, the differences in drug distribution and body volume in children. These factors can cause prolonged recovery and increased risk of PORC in children especially infants and neonates.8

Sugammadex has been shown to be a safe and superior agent to reverse neuromuscular blockade when compared to neostigmine in patients of various age groups in western population but it has not been studies in Indian population especially children. Most of the studies in literature have utilised sugammadex to reverse neuromuscular blockade produced by rocuronium and there are no controlled trials for its use to reverse effect of vecuronium.9-11 The aim of this study is to compare the efficacy and safety of sugammadex and neostigmine on reversing neuromuscular blockade produced by vecuronium in paediatric patients undergoing various surgical procedures under general anaesthesia and endotracheal intubation.

 

 

The relevance and expected outcome of the proposed study:

Neostigmine + Atropine / Glycopyrrolate are used as Reversal agent for countering the effects of residual neuromuscular blockade at the end of surgery. Since neostigmine is not selective for nicotinic receptors at neuromuscular junction and it exerts muscarinic effects as well.

Sugammadex is a newly introduced reversal agent which is highly specific for steroidal type of muscle relaxants like vecuronium and rocuronium. This drug is devoid of side effects of neostigmine and atropine combination. Sugammadex is said to fasten recovery from muscle relaxation and has negligible incidence of recurrent curarization in recovery room, thus enhances safety of patients. Its usage lead to faster recovery from muscle relaxation, no side effects of neostigmine + atropine combination, reduced incidence of recurrence of muscle relaxation in recovery room and reduced length of ICU stay.


Sugammadex has already become standard of care drug as far as reversal agents are considered in the western world but has been introduced very recently in Indian market after DCGI has approved its clinical use in Indian patients. Hence till now only Neostigmine and Atropine / Glycopyrrolate combination was used as reversal agent in all the patients in India. Hence, present study will generate the data of clinical usage of Sugammadex in Indian patients.



 
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