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CTRI Number  CTRI/2024/12/078350 [Registered on: 19/12/2024] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative study of Sugammadex and Neostigmine in patients undergoing various lung surgeries  
Scientific Title of Study   A Randomized comparative study of Sugammadex versus Neostigmine on Postoperative residual neuromuscular blockade in patients undergoing lung surgeries in general anaesthesia in the Department of Anaesthesia SMS Medical College Jaipur  
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 Indu Verma  
Designation  Senior Professor  
Affiliation  Sawai Man Singh Medical College and Hospitals  
Address  Department of Anaesthesia SMS Medical College and Hospital Jaipur Rajasthan 302004

Jaipur
RAJASTHAN
302004
India 
Phone  9413622967  
Fax    
Email  dr.induverma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Indu Verma  
Designation  Senior Professor  
Affiliation  Sawai Man Singh Medical College and Hospitals  
Address  Department of Anaesthesia SMS Medical College and Hospital Jaipur Rajasthan 302004

Jaipur
RAJASTHAN
302004
India 
Phone  9413622967  
Fax    
Email  dr.induverma@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrYadav Jyoti  
Designation  Resident Doctor  
Affiliation  SMS Medical College and Hospital  
Address  Department of Anaesthesia SMS Medical College and Hospital Jaipur Rajasthan 302004

Jaipur
RAJASTHAN
302004
India 
Phone  8464883478  
Fax    
Email  jy8187280@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia,2nd floor,Dhanavantri complex SMS Medical College and attached Hospital Jaipur Rajasthan 302004 
 
Primary Sponsor  
Name  SMS Medical College and Hospitals  
Address  Department of Anaesthesia,2nd floor Dhanavantri complex SMS Medical College Jaipur Rajasthan 302004 
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 Indu Verma   Cardio thoracic OT,SMS Medical College and Hospital   Department of Anaesthesia,2nd floor Dhanavantri complex,SMS Medical College and Hospital Jaipur Rajasthan 302004
Jaipur
RAJASTHAN 		 9413622967

dr.induverma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OFFICE OF THE ETHICS COMMITTEE SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Injection Neostigmine 0.07mg/kg  Injection Neostigmine 0.07mg/kg iv will be administered immediately after surgery completion and reappearance of respiratory movements  
Intervention  Injection Sugammadex   Injection Sugammadex 2mg/kg iv will be administered immediately after surgery completion and reappearance of respiratory movement 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients willing to give written consent
2.Patients age18-60years belonging to either sex of age group
3.Patients with an American Society of Anaesthesiologist (ASA)class 1,2&3
4.Patients undergoing elective lung surgery  
 
ExclusionCriteria 
Details  1.Patients with history of neuromuscular disease.
2.Patients with history of heart failure,vascular disease,increased intracerebral pressure.
3.Patients with previous history of anaphylaxis/allergy to anaesthetic drugs.
4.Patients with anticipated difficult intubation.
5.Patients with history of malignant hyperthermia. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Mean Recovery time fron Neuromuscular blockade antagonist to achieve train of four ratio 0.9 at the time of extubation.  1.Mean Recovery time fron Neuromuscular blockade antagonist to achieve train of four ratio 0.9 at the time of extubation. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Mean change in Hemodynamic parameters at 1 3 5 7 & 10minutes after extubation   1.Mean change in Hemodynamic parameters at 1 3 5 7 & 10minutes after extubation  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 2 
Date of First Enrollment (India)   30/12/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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   Purpose of this study is to compare the effect of Sugammadex versus Neostigmine on post operative residual neuromuscular blockade recovery in patients undergoing lung surgeries under general anaesthesia.This is helpful for patients in view of better postoperative motor power recovery. 
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