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CTRI Number  CTRI/2023/06/054581 [Registered on: 30/06/2023] Trial Registered Prospectively
Last Modified On: 29/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between two neuromuscular blockade reversal agents by ultrasonographic assessment  
Scientific Title of Study   A randomized study to compare sugammadex with neostigmine for recovery of muscle function by ultrasonographic assessment in patients undergoing laparoscopic cholecystectomy 
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 Sreelakshmi S 
Designation  Post graduate, 1st year resident 
Affiliation  Lady Hardinge Medical College and Associated Hospitals 
Address  Department of anaesthesia, Lady Hardinge medical college, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India

Central
DELHI
110001
India 
Phone  9840410359  
Fax    
Email  sreelakshmis812@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anshu Gupta 
Designation  Director Professor 
Affiliation  Lady Hardinge Medical College and Associated Hospitals 
Address  Department of anaesthesia, Lady Hardinge medical college, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India
Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India
Central
DELHI
110001
India 
Phone  9711000264  
Fax    
Email  anug71@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Nishant Kumar 
Designation  Professor 
Affiliation  Lady Hardinge Medical College and Associated Hospitals 
Address  Department of anaesthesia, Lady Hardinge medical college, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India
Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India
Central
DELHI
110001
India 
Phone  9811934659  
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Lady Hardinge Medical College and Associated Hospitals C-604, Shaheed Bhagat Singh Road, Diz Area, Connaught Place New Delhi - 110001 Delhi NCR, India 
 
Primary Sponsor  
Name  Lady Hardinge Medical College and Associated Hospitals 
Address  Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India 
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 Sreelakshmi S  Sucheta Kriplani Hospital Main Operation Theatre  Department of anaesthesia, Lady Hardinge medical college, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India
Central
DELHI 
9840410359

sreelakshmis812@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical committee for Human Research, Lady Hardinge Medical College  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Neostigmine  Patients will receive neostigmine for reversal of neuromuscular block in dose 0.05mg/kg + glycopyrrolate 0.01mg/kg in immediate post surgery period at the time of reversal 
Intervention  Sugammadex  Patients will receive sugammadex for reversal of neuromuscular block in dose 2mg/kg in immediate post surgery period at the time of reversal  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age between 18-65 years old
2. Patients of either sex
3. ASA I and ASA II
4. Patients undergoing laparoscopic cholecystectomy
 
 
ExclusionCriteria 
Details  1.Patients with central or peripheral nervous system diseases, such as polio, parkinson’s disease, peripheral neuropathy, etc.
2.Patients with neuromuscular diseases, such as myasthenia gravis, multiple sclerosis, atrophic myotonia, etc.
3. Patients with hepatic/renal disorders
4. Patients with BMI > 30
5.Patients with known history of allergy to drugs used in the study
6.Patients taking oral contraceptive pills
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of mean percentage change in diaphragm thickening fraction (DTF) from baseline to 30 minutes post-operatively between the both groups  30 minutes post-operatively  
 
Secondary Outcome  
Outcome  TimePoints 
1.Mean percentage change in diaphragmatic excursion (DE) from baseline to 30 minutes post-operatively
2.Mean percentage change in internal oblique muscle thickening fraction (IO TF) from baseline to 30 minutes post-operatively 
1.30 minutes post-operatively
2.30 minutes post-operatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/07/2023 
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="4"
Days="25" 
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  

Study will be conducted after approval from the institutional ethical committee (IEC) and will be registered with clinical trial registry - India (CTRI). A detailed pre-anaesthetic check up including detailed history,  physical examination baseline investigations as per clinical requirements will be performed. A written and informed voluntary consent will be obtained from the patient.

An investigator with no further involvement in the study will generate a list of random numbers by using computer randomization and patients will be randomized to one of the two study groups: Group (I) and Group (II) in the operating room prior to surgery and a code will be allotted with no restrictions or bias.

Group (I) : Patients will receive sugammadex for reversal of neuromuscular block in dose 2mg/kg

Group (II) : Patients will receive neostigmine for reversal of neuromuscular block in dose 0.05mg/kg + glycopyrrolate 0.01mg/kg

 The results of the allocation will be concealed in sequentially numbered sealed opaque envelopes mentioning the code and the group number. The independent observer will be unaware of the drug being administered.  Drugs as mentioned in the randomized envelope will be prepared in a 10ml syringe by a resident not  involved in the study and will be labelled with the code allotted to that particular patient.

Patients will be kept nil per oral (NPO) for at least 8 hours prior to surgery as per standard     guidelines. Patients will be pre-medicated with tablet alprazolam 0.25mg HS and tablet pantoprazole 40mg HS and 6AM on morning of surgery with sips of water. Baseline diaphragm thickening fraction (DTF), diaphragmatic excursion (DE) and internal oblique muscle thickening fraction (IO TF) will be measured pre-operatively.

Ultrasonography will be performed during spontaneous breathing to help identify the moving  diaphragm using  SonositeTM Edge II Total ultrasound machine.

The diaphragm thickening fraction (DTF) will be measured using curvilinear  transducer (2 to 5 MHz) in two-dimensional B-mode ultrasound at the zone of apposition during inspiration and expiration using intercostal approach (8th - 9th intercostal space) at the level of mid axillary line. The thickening fraction will be calculated as (thickness at end inspiration-thickness at end expiration)/thickness at end expiration.

The diaphragmatic excursion (DE) will be measured with anterior subcostal view at midclavicular line in M- mode.  The same transducer will be used, directed medially, cranially, and dorsally, so that the ultrasound beam reaches the posterior third of the right diaphragm. Either dome of diaphragm will be measured using liver and spleen window, whichever is clearly visible.

The internal oblique muscle thickening fraction(IO TF) will be measured using a linear probe (6 to 13 MHz) positioned on the right anterior axillary line, midway between the inferior border of the rib cage and the iliac crest, perpendicular to the abdominal wall. The thickness of the internal oblique muscle will be first measured at end inspiratory and at maximum contraction when the patient is told to cough with maximum strength. IO TF = (end coughing thickness-end inspiratory thickness)/end inspiratory thickness.

Patients will be wheeled in to the operation theatre and all routine monitors will be attached including neuromuscular monitor (NMT) and bispectral index (BIS).  Intravenous access will be obtained. Patients will be pre-medicated with intravenous fentanyl 2 µg/ kg.  Anaesthesia will be induced intravenously with slow administration of propofol 1.5-2 mg/kg to achieve a BIS of < 60 . Rocuronium 0.6mg/kg will be administered intravenously to facilitate endotracheal intubation under direct vision with an appropriately sized endotracheal tube. 

Anaesthesia will be maintained with sevoflurane in oxygen (40%) + air. Age adjusted  minimum alveolar concentration (aaMAC) will be adjusted to maintain a BIS of 40-60. Electrocardiograph, heart rate, blood pressure,  SpO2,  EtCO2, aaMAC, NMT and temperature will be monitored throughout. 

Injection fentanyl will be repeated hourly at a dose of 1 µg/ kg. Injection paracetamol 1 gram will be administered during the surgery and inj. Ondansetron 0.08mg/kg at the end of pneumoperitoneum. After the end of surgery, the residual neuromuscular block will be reversed with  sugammadex 2mg/kg or neostigmine 0.05mg/kg with glycopyrrolate 0.01mg/kg according to the group allocated when  when the train-of-four (TOF) count is 4. Inhalational anaesthetic agents will be stopped after administration of reversal agent and trachea will be extubated once the patient is awake.

Diaphragm thickening fraction, diaphragmatic excursion and internal oblique muscle thickening fraction will be measured post extubation, at 30 minutes and 1 hour after extubation.  If the patient complains of pain post-operatively, or the numeric pain rating scale (NRS) >3,  fentanyl will be repeated at 0.5 µg/ kg. All the above measurements will be made only when the NRS < 3. Post extubation, the patient will be monitored for any side effects such increased glandular secretions, bradycardia, vomiting, diarrhoea, chest discomfort, blurred or loss of vision, anaphylaxis, laryngospasm etc.

 
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