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CTRI Number  CTRI/2023/06/053360 [Registered on: 01/06/2023] Trial Registered Prospectively
Last Modified On: 26/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Injection Sugammadex after muscle relaxation agents in Cardiac Catheterisation Laboratory  
Scientific Title of Study   Sugammadex Versus Neostigmine: A comparative Study of Efficacy and Safety in the Cath lab 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjeeta Umbarkar 
Designation  Professor(Add.) and HOD 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Cardiac Anaesthesia, Seth GS Medical College and KEM Hospital, Parel, Mumbai, Maharashtra 400012

Mumbai
MAHARASHTRA
40012
India 
Phone  9323273435  
Fax    
Email  sanjeeta69@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Sanjeeta Umbarkar 
Designation  Professor(Add.) and HOD 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Cardiac Anaesthesia, Seth GS Medical College and KEM Hospital, Parel, Mumbai, Maharashtra 400012

Mumbai
MAHARASHTRA
40012
India 
Phone  9323273435  
Fax    
Email  sanjeeta69@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Sanjeeta Umbarkar 
Designation  Professor(Add.) and HOD 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Cardiac Anaesthesia, Seth GS Medical College and KEM Hospital, Parel, Mumbai, Maharashtra 400012

Mumbai
MAHARASHTRA
40012
India 
Phone  9323273435  
Fax    
Email  sanjeeta69@yahoo.com  
 
Source of Monetary or Material Support  
Research grant from Institutional Research Society, Seth GS Medical College and KEM hospital, Parel, Mumbai 
 
Primary Sponsor  
Name  Institutional Research Society 
Address  Institutional Research Society, Seth G S Medical College and KEM hospital, Mumbai 
Type of Sponsor  Research institution 
 
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 Sanjeeta Umbarkar  KEM hospital Catheter lab  Catheter lab, CVTS building, KEM hospital and Seth GS Medical College, PArel, Mumbai, 400012
Mumbai
MAHARASHTRA 
9323273435

sanjeeta69@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q20-Q28||Congenital malformations of the circulatory system, (2) ICD-10 Condition: I00-I99||Diseases of the circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Neostigmine  Reversal with 0.05 mg/ kg of Neostigmine and Inj Glycopyrrolate 0.008 mg/kg after completion of procedure and after two twitches of Train Of Four. 
Intervention  Sugammadex  Reversal with 2 mg/kg dose of Sugammadex after the completion of procedure and after two twitches on Train Of Four. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA grade I-IV patients.
2. Age between 20 and 60 years.
3. Patients posted for elective cardiac catheterisation procedures in the cathlab.
4. Availability of informed consent and willingness of the patient to be a part of the study.
 
 
ExclusionCriteria 
Details  1. Patients requiring emergency surgery.
2. Incapacity to consent
3. Patient with renal, hepatic and pre-existing pulmonary comorbidities.
4. Patients allergic to Sugammadex, neostigmine or glycopyrrolate.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Our primary outcome is to note the time(in minutes) from re-appearance of second twitch to TOF ratio more than 0.9 with sugammadex compared to neostigmine groups. This is a parameter to measure the efficacy of the study drugs.  Baseline, Just before extubation 
 
Secondary Outcome  
Outcome  TimePoints 
to detect the occurrence of any adverse events after administration of study drug  2 hours, 4 hours, 6 hours, 8 hours 
2) To measure the time to PACU discharge readiness using the modified Aldrete score in both the study groups.  two hours after shifting to icu,
four hours after shifting to icu, six hours after shifting to icu, eights hours after shifting to icu 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   10/06/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Muscle relaxation is a core component of anaesthesia which helps facilitate endotracheal intubation and provides optimal surgical operating conditions.

Anaesthetists have access to a wide variety of Neuromuscular blocking agents (NMBAs) for this purpose. Following surgery, relaxation is no longer needed, hence it is important that effects of the NMBAs be quickly and effectively terminated. Residual neuromuscular blockade after surgery has been associated with adverse patient outcomes including airway obstruction, hypoxia, respiratory complications, and symptoms of muscle weakness and dyspnea. The use of neuromuscular blockade, especially without reversal, has been associated with an increased risk of postoperative pneumonia.

Cath lab procedures like percutaneous trans-catheter device closure procedures are nowadays a routine treatment of cardiac lesions like septal defects, ruptured sinus of valsalva .Most of these procedures are done under general anaesthesia with the muscle relaxation and maintenance with inhalational agents like sevoflurane to ensure precision of catheter movements during procedures. The duration of action of NMBs in this group of patients are prolonged because of low ambient temperature and altered cardiovascular physiology and there is an added risk of recurarization in these patients after reversal and shifting to PACU. Hence this represents a group of patients where quick and effective reversal at the end of the procedure can facilitate earlier extubation and reduced post operative pulmonary complications.The added advantages of reduced ICU stay becomes very relevant in our Cath lab which has a very high turnover rate. Hence Sugammadex if proven to be quicker in onset and more effective can replace the current reversal agent Neostigmine thus helping in faster reversal of neuromuscular blockade and better patient care.

Therefore, we plan to conduct a randomized-controlled trial to compare the efficacy and safety of sugammadex and neostigmine with respect to reversal of moderate NMB (from re-appearance of second twitch to Train Of Four ratio >0.9) in patients undergoing cath lab procedures under general anaesthesia. Our secondary outcomes will be to detect the occurrence of adverse events if any and time taken to PACU discharge readiness using the modified Aldrete score with sugammadex compared to neostigmine groups. 
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