Comparison of Sugammadex and Neostigmine for reversal of neuromuscular blockade in children undergoing surgery with general anaesthesia

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/02/050085
• Lead Sponsor: Sanjay Gandhi Post Graduate Institute of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-03
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Aims	At 15 minutes after recovery from neuromuscular blockade
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
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.	At 15 minutes after recovery from neuromuscular blockade

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Aarti Agarwal

Principal investigator

9918246222

aarti_agarwal000@yahoo.co.uk