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CTRI Number  CTRI/2025/03/082444 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 16/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   COMPARISION OF REVERSAL AGENTS SUGAMADEX V/S NEOSTIGMINE FOR NEUROMUSCULAR MONITORING IN PATIENTS UNDERGOING SPINE SURGERIES 
Scientific Title of Study   COMPARISION OF SUGAMMADEX VERSUS NEOSTIGMINE ON AMPLITUDE AND LATENCY FOR TRANSCRANIAL MOTOR EVOKED POTENTIAL MONITERING IN PATIENTS UNDERGOING SPINE SURGERIES. 
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 MANOJ KUMAR GIRI  
Designation  PROFESSOR  
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences  
Address  Department of Anaesthesiology and Critical Care medicine,Dr Ram Manohar Lohia Institute of Medical Sciences Vibhuti khand Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  9044479649  
Fax    
Email  drmanoj.giri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MANOJ KUMAR GIRI  
Designation  PROFESSOR  
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences  
Address  Department of Anaesthesiology and Critical Care medicine,Dr Ram Manohar Lohia Institute of Medical Sciences Vibhuti khand Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  9044479649  
Fax    
Email  drmanoj.giri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MANOJ KUMAR GIRI  
Designation  PROFESSOR  
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences  
Address  FACULTY APARTMENT Dr. RMLIMS VIBHUTI KHAND LUCKNOW

Lucknow
UTTAR PRADESH
226010
India 
Phone  9044479649  
Fax    
Email  drmanoj.giri@gmail.com  
 
Source of Monetary or Material Support  
Dr. Ram Manohar Lohia Institute of Medical Sciences Vibhuti Khand Lucknow U.P. 226010 
 
Primary Sponsor  
Name  Dr Ram Manohar Lohia Institute of Medical Sciences  
Address  Dr Ram Manohar Lohia Institute of Medical Sciences, Vibhuti khand Lucknow, U.P. 226010 
Type of Sponsor  Government 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 MANOJ KUMAR GIRI  Ram Manohar Lohia Institute of Medical Sciences, Lucknow  OT 1 AND 2, SECOND FLOOR DEPARTMENT OF NEUROSURGERY DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES
Lucknow
UTTAR PRADESH 
9044479649

drmanoj.giri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, (2) ICD-10 Condition: G63||Polyneuropathy in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Administration of neostigmine  Administration of neostigmine for Reversal of neuromuscular blockade after intubation 
Intervention  sugammadex/neostigmine administration  At first intubating dose of vecuronium @ 0.8mg/kg is given via intravenous route and then after intubation patient will be reversed via sugammadex/neostigmine @8mg/kg and neostigmine @ 0.05mg/kg intravenous . frequency- once only 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged 18 to 65 years
ASA I and II.
 
 
ExclusionCriteria 
Details  BMI more than 35 kg/m2
H/o Epilepsy
Transcranial evoked motor potential site infection
Pregnancy
Hb less than 10mg/dl
Neurological dysfunction in both upper extremities. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Reversal with sugammadex facilitates the TecMEP monitoring after use of muscle relaxant and it will shorten the time as compared to neostigmine.  At 5,10,20,30 and 60 minutes after dural opening.  
 
Secondary Outcome  
Outcome  TimePoints 
observation of Peak airway pressure changes & Bucking event  At 5,10,20,30 & 60 minutes after reversal. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/04/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Intraoperative neuromonitoring (IONM) is frequently used
during spinal surgeries that carry the risk of neurological damage. Real-time
detection of compromised nerve function by IONM allows the surgeon to
address possible causes and avoid permanent injury. Transcranial motor evoked
potentials (TceMEPs) are muscle action potentials elicited by transcranial brain
stimulation and have been the most widely used method of IONM because of
their high sensitivity for detecting neurologic injury. Electrical stimulation
applied over the motor cortex allows compound motor action potentials to be
recorded peripherally. TceMEP monitoring plays an important role in preventing
motor dysfunction during spinal surgery. Neuromuscular blockade (NMB) acts at
the neuromuscular junction and leads to a dramatic loss of TceMEP signals. For
most cases requiring TceMEPs, the use of NMB is omitted after intubation.
However, evidence is still conflicting regarding the optimal level of NMB during
such monitoring since appropriate muscle relaxation facilitates surgery,
optimizes anaesthetic management, and prevents patient movement. Partial
NMB (pNMB) induced by constant infusion of muscle relaxants according to the
amplitude of muscle responses to “train of four” TOF has been applied in
TceMEP monitoring. Notably, this approach increases technical and interpretive
complexity and runs the risk of inadvertently disabling TceMEPs at a critical
moment. The incidence of monitoring failure and false-positive results was
increased under pNMB. Sugammadex is a novel reversal agent that selectively
binds to vecuronium in the plasma and consequently lowers the vecuronium
concentration at the neuromuscular junction. Multiple studies have confirmed
the efficacy of reversing various levels of rocuronium block by Sugammadex.
We hypothesized that the muscle relaxation reversal effect of sugammadex can
increase the success rate of TceMEP recording in spinal surgery as compared to
neostigmine. The study aimed to investigate the administration of Sugammadex
versus Neostigmine after tracheal intubation shortens time to successful
intraoperative neuromonitoring during spine surgery
 
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