sugammadex and neostigmine for reversal of rocuronium induced muscle relaxation in patients undergoing general anaesthesia

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2023/09/057991

Lead Sponsor: ROHILKHAND MEDICAL COLLEGE

Brief Summary: Modern anaesthesia includes analgesia, amnesia andmuscle relaxation caused by neuromuscular blockers. Muscle relaxation makesendotracheal intubation easier and facilitates operations in large bodycavities like the abdomen and thorax without the need for very deepanaesthesia. Drugs designed to relax muscles do so by stopping acetylcholinefrom binding to its receptor. It is necessary to use some kind of artificialrespiration when the diaphragm and intercostal muscles in the chest areparalysed. When the laryngeal muscles are also paralysed, an endotracheal tubeis typically required to protect the airway.

The effects of musclerelaxants are commonly reversed at the end of surgery by anticholinesterase drugs, which are administered in combination with muscarinic anticholinergic drugs to minimize side effects. Pancuronium,rocuronium, vecuronium, cisatracurium, atracurium and mivacurium are someexamples of skeletal muscle relaxants in use now a days.

Rocuronium is a monoquaternary steroid analogue ofvecuronium, designed to provide a rapid onset of action. It undergoes no metabolismand is mostly removed by the liver and a small amount by the kidneys. Its duration of action is not significantly affected by renal disease,but it is modestly prolonged by severe liver failure and pregnancy.

Acetylcholine binding to nicotinic cholinergicreceptors on the motor end-plate is necessary for normal neuromusculartransmission. The nondepolarizing relaxant’s redistribution, diffusion,excretion and metabolism from the body are all necessary for blockade reversal(spontaneous reversal), which is frequently aided by certain reversal drugs(pharmacological reversal). In order to restore normal neuromusculartransmission, cholinesterase inhibitors indirectly increase the quantity ofacetylcholine to compete with the nondepolarizing agent.

Neostigmine is made up of a quaternary compound andcarbamate moiety. Neostigmine’s (0.05 mg/kg) effects often start to show afterfive minutes, peak after ten, and last for more than an hour. The action timeof this drug is prolonged in elderly patients. When an anticholinergic drug isadministered beforehand or concurrently, muscarinic adverse effects arereduced. The conditions urinary bladder atony, paralytic ileus and myastheniagravis are also managed with neostigmine.

Sugammadex, a type of modified gamma -cyclodextrin,is a special substance that selectively binds relaxants. Due to itsthree-dimensional structure, a 1:1 water-soluble guest-host complex is tightlyformed. This prevents the medication from interacting with nicotinicacetylcholine receptors and causing a neuromuscular block in extracellularfluid. Sugammadex does not need to be administered with an antimuscarinicmedication because it is generally excreted intact through the kidneys. Bothsuperficial and deep rocuronium-induced neuromuscular blockade are consistentlyreversed quickly and effectively by it. Sugammadex is not advised for peoplewith severe kidney disease (creatine clearance 30 mL/min) due to its renalexcretion.

This study is being done as sugammadex is a newerdrug and there are fewer studies done in comparison with neostigmine. Therefore,the present study is designed as a randomised controlled trial to evaluate andcompare the sugammadex and neostigmine related side effects on both the groupsafter reversal.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 98

Inclusion Criteria

1.Age: 18 years to 60 years 2.Informed and written consent from patients 3.ASA grade I & II 4.Elective surgeries under general anaesthesia.

Exclusion Criteria

1.Patient with suspected difficult intubation 2.Patients with neuromuscular disorders 3.Patients with known or suspected significant renal or hepatic dysfunction.
4.Allergy or contraindication to any drug affecting neuromuscular block or general anaesthesia 5.Pregnancy 6.Breastfeeding.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To compare fast and complete recovery of neuromuscular function between sugammadex and neostigmine.	In 30, 60, and 120 minutes, the level of post operative residual curarization and postoperative discomfort will be evaluated. The patients will be transferred to the ward after being monitored for 2 hours for adverse symptoms such as nausea, vomiting, bradycardia, hypotension, sedation, and others.
2.To determine post operative residual curarization incidences in both groups.	In 30, 60, and 120 minutes, the level of post operative residual curarization and postoperative discomfort will be evaluated. The patients will be transferred to the ward after being monitored for 2 hours for adverse symptoms such as nausea, vomiting, bradycardia, hypotension, sedation, and others.
4.To document side effects after reversal in both groups	In 30, 60, and 120 minutes, the level of post operative residual curarization and postoperative discomfort will be evaluated. The patients will be transferred to the ward after being monitored for 2 hours for adverse symptoms such as nausea, vomiting, bradycardia, hypotension, sedation, and others.
3.To assess hemodynamic changes in both groups.	In 30, 60, and 120 minutes, the level of post operative residual curarization and postoperative discomfort will be evaluated. The patients will be transferred to the ward after being monitored for 2 hours for adverse symptoms such as nausea, vomiting, bradycardia, hypotension, sedation, and others.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): OPERATION THEATRE Rohilkhand Medical College and Hospital
🇮🇳
Bareilly, UTTAR PRADESH, India
OPERATION THEATRE Rohilkhand Medical College and Hospital
🇮🇳Bareilly, UTTAR PRADESH, India
Dr Richa Chandra
Principal investigator
8279783945
rinkichandra@yahoo.com