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
|
|
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
|
|
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. |