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CTRI Number  CTRI/2023/09/057991 [Registered on: 25/09/2023] Trial Registered Prospectively
Last Modified On: 22/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   sugammadex and neostigmine for reversal of rocuronium induced muscle relaxation in patients undergoing general anaesthesia 
Scientific Title of Study   Comparison of sugammadex and neostigmine for reversal of rocuronium induced muscle relaxation in patients undergoing general Anaesthesia: A Randomized Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kirti Gupta 
Designation  Junior Resident 
Affiliation  Rohilkhand medical college and hospital bareilly 
Address  Department of Anaesthesiology Rohilkhand medical college and hospital bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  9591689465  
Fax    
Email  guptakirti09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Richa Chandra 
Designation  Professor 
Affiliation  Rohilkhand medical collega dn hospital bareilly 
Address  DEPARTMENT OF ANAESTHESIA ROHILKHAND MEDICAL COLLEGE AND HOSPITAL BAREILLY UP

Bareilly
UTTAR PRADESH
243006
India 
Phone  8279783945  
Fax    
Email  rinkichandra@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR ANKUR GARG 
Designation  ASSOCIATE PROFESSOR 
Affiliation  ROHILKHAND MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIA ROHILKHAND MEDICAL COLLEGE AND HOSPITAL BAREILLY UP

Bareilly
UTTAR PRADESH
243006
India 
Phone  9650715363  
Fax    
Email  ankurgarg.gsvm@gmail.com  
 
Source of Monetary or Material Support  
ROHILKHAND MEDICAL COLLEGE BAREILLY 
 
Primary Sponsor  
Name  ROHILKHAND MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIA ROHILKHAND MEDICAL COLLEGE AND HOSPITAL BAREILLY UP 243006 
Type of Sponsor  Private medical college 
 
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 Richa Chandra  OPERATION THEATRE Rohilkhand Medical College and Hospital   DEPARTMENT OF ANAESTHESIA ROHILKHAND MEDICAL COLLEGE AND HOSPITAL PILIBHIT BYPASS ROAD
Bareilly
UTTAR PRADESH 
8279783945

rinkichandra@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTE Rohilkhand Medical College and Hospital Bareilly UP  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  INJ. NEOSTIGMINE  GROUP 2: Inj. GROUP 1: Inj. Neostigmine 0.05mg/kg will be given at the time of reversal after a peripheral nerve stimulator evaluation in which it shows a reading of 0.4 on train of four. Following confirmation of recovery from anaesthesia and muscle relaxation, extubation will be performed after confirming a train of four ratio of 0.9 on neuromuscular monitor. 
Intervention  INJ. SUGAMMADEX  GROUP 1: Inj. Sugammadex 2mg/kg will be given at the time of reversal after a peripheral nerve stimulator evaluation in which it shows a reading of 0.4 on train of four. Following confirmation of recovery from anaesthesia and muscle relaxation, extubation will be performed after confirming a train of four ratio of 0.9 on neuromuscular monitor. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To compare fast and complete recovery of neuromuscular function between sugammadex and neostigmine.
2. To determine post operative residual curarization incidences in both groups.
3. To assess hemodynamic changes in both groups.
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.
 
 
Secondary Outcome  
Outcome  TimePoints 
NONE  NONE 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
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)   02/10/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Modern anaesthesia includes analgesia, amnesia and muscle relaxation caused by neuromuscular blockers. Muscle relaxation makes endotracheal intubation easier and facilitates operations in large body cavities like the abdomen and thorax without the need for very deep anaesthesia. Drugs designed to relax muscles do so by stopping acetylcholine from binding to its receptor. It is necessary to use some kind of artificial respiration when the diaphragm and intercostal muscles in the chest are paralysed. When the laryngeal muscles are also paralysed, an endotracheal tube is typically required to protect the airway.

The effects of muscle relaxants 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 some examples of skeletal muscle relaxants in use now a days.

Rocuronium is a monoquaternary steroid analogue of vecuronium, designed to provide a rapid onset of action. It undergoes no metabolism and 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 cholinergic receptors on the motor end-plate is necessary for normal neuromuscular transmission. 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 neuromuscular transmission, cholinesterase inhibitors indirectly increase the quantity of acetylcholine to compete with the nondepolarizing agent.

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

Sugammadex, a type of modified gamma -cyclodextrin, is a special substance that selectively binds relaxants. Due to its three-dimensional structure, a 1:1 water-soluble guest-host complex is tightly formed. This prevents the medication from interacting with nicotinic acetylcholine receptors and causing a neuromuscular block in extracellular fluid. Sugammadex does not need to be administered with an antimuscarinic medication because it is generally excreted intact through the kidneys. Both superficial and deep rocuronium-induced neuromuscular blockade are consistently reversed quickly and effectively by it. Sugammadex is not advised for people with severe kidney disease (creatine clearance 30 mL/min) due to its renal excretion.

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

 

 
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