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
|
|
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
|
|
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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