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CTRI Number  CTRI/2024/04/065600 [Registered on: 12/04/2024] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing recovery features of patients undergoing general anaesthesia with rocuronium as muscle relaxant and recieving sugammadex or neostigmine and glycopyrollate for reversal. 
Scientific Title of Study   A study comparing recovery characteristics of patients recieving either Sugammadex or Neostigmine and Glycopyrollate, for reversal of rocuronium induced Neuromuscular block 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sameer Akthar B 
Designation  DNB Resident 
Affiliation  Manipal Hospital 
Address  MANIPAL HOSPITAL HAL OLD AIRPORT ROAD BANGALORE manipal hospital
MANIPAL HOSPITAL HAL OLD AIRPORT ROAD BANGALORE manipal hospital
Bangalore
KARNATAKA
560017
India 
Phone  8111053116  
Fax    
Email  aktharsameer@outlook.com  
 
Details of Contact Person
Scientific Query  
Name  DR H S MURTHY 
Designation  HOD, SENIOR CONSULTANT 
Affiliation  Manipal Hospital 
Address  MANIPAL HOSPITAL HAL OLD AIRPORT ROAD BANGALORE manipal hospital
MANIPAL HOSPITAL HAL OLD AIRPORT ROAD BANGALORE manipal hospital
Bangalore
KARNATAKA
560017
India 
Phone  8111053116  
Fax    
Email  drhsmurthy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sameer Akthar B 
Designation  DNB Resident 
Affiliation  Manipal Hospital 
Address  MANIPAL HOSPITAL HAL OLD AIRPORT ROAD BANGALORE manipal hospital
manipal hospital
Bangalore
KARNATAKA
560017
India 
Phone  8111053116  
Fax    
Email  aktharsameer@outlook.com  
 
Source of Monetary or Material Support  
Manipal Hospital, No 98, Rustum Bagh, Old Airport Road, bangalore, Karnataka 
 
Primary Sponsor  
Name  Manipal Hospital 
Address  No 98, Rustum Bagh, Old Airport Road, Bangalore, Karnataka, 560017, India 
Type of Sponsor  Private hospital/clinic 
 
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 H S Murthy  Manipal Hospital  Department of Anaesthesia, No. 98, Rustum Bagh, Old Airport Road,
Bangalore
KARNATAKA 		 8111053116

drhsmurthy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Manipal Hospital, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (3) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Neostigmine and Glycopyrollate  Neostigmine 2.5 mg and glycopyrollate 0.4 mg at TOF count of 2. Given only once at the time of extubation. 
Intervention  Sugammadex  2mg/kg given at TOF count of 2. Given only once at the time of extubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists grades 1, 2, and 3 patients aged 18–60 years, coming for elective laparoscopic surgeries (lasting one to three hours) will be recruited for the study.  
 
ExclusionCriteria 
Details  1. Patients with cardiorespiratory abnormalities (New York Heart Association heart failure grades 3 and 4.
2. Known allergy to Rocuronium.
3. Renal insufficiency (eGFR<60).
4. Liver dysfunction (liver enzymes—serum glutamic oxaloacetic transaminase/ serum glutamic pyruvic transaminase values elevated by more than 50% of normal).
• Underlying neuromuscular disease or the use of drugs known to interfere with neuromuscular transmission.
• Intraoperative hypothermia (core temperature less than 35°C).
• Known Emphysema.
• Unwillingless to perform PFT.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time taken for complete reversal of neuromuscular block  Reversal given at TOF count of 2 and time taken to reach TOF ratio 0.9. It is checked at the end of each case at the time of extubation. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare post operative respiratory function in terms of PFT   PFT to be done in post anaesthesia care unit 20 minute after extubation 
 
Target Sample Size   Total Sample Size="109"
Sample Size from India="109" 
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 4 
Date of First Enrollment (India)   30/04/2024 
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="0"
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   In this study we are comparing the recovery characteristics of patients receiving either Sugammadex or Neostigmine and Glycopyrollate for reversal of Rocuronium induced Neuromuscular blockade. We compare the time taken for complete reversal and other complications like change in respiratory function, duration of stay IN PACU, PONV and other complications. 
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