| CTRI Number |
CTRI/2024/12/078115 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| 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 how sugammadex and neostigmine work to reverse anesthesia in patients having chest surgery |
|
Scientific Title of Study
|
Sugammadex Vs Neostigmine As A Reversal Agent In Patient Undergoing Thoracic Surgery Prospective randomized Observational Study |
| 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 Vinod Rajan |
| Designation |
Post Graduate |
| Affiliation |
D Y Patil School Of Medicine |
| Address |
A Block , Second Floor , Department of Anesthesia
D Y Patil Hospital
Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9400012520 |
| Fax |
|
| Email |
vinu.rajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula Sarkar |
| Designation |
Professor |
| Affiliation |
D Y Patil School Of Medicine |
| Address |
A Block , Second Floor , Department of Anesthesia
D Y Patil Hospital
Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9869984017 |
| Fax |
|
| Email |
drmanjusarkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjula Sarkar |
| Designation |
Professor |
| Affiliation |
D Y Patil School Of Medicine |
| Address |
A Block , Second Floor , Department of Anesthesia
D Y Patil Hospital
Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
MAHARASHTRA
400706
India |
| Phone |
9869984017 |
| Fax |
|
| Email |
drmanjusarkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| A Block , Second Floor , Department of Anesthesia
D Y Patil Hospital
Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706 |
|
|
Primary Sponsor
|
| Name |
D Y Patil School Of Medicine |
| Address |
A Block , Second Floor , Department of Anesthesia
D Y Patil Hospital
Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vinod Rajan |
D Y Patil Hospital |
A Block , Second Floor , Department of Anesthesia
D Y Patil Hospital
Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA |
9400012520
vinu.rajan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee for Biomedical and Health research (IECBH) of Dr D Y Patil Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj.Sugammadex 4mg/kg at the end of surgery before extubation |
Dosage : 4mg/kg body weight
Route : Intravenous
Duration : over 5seconds
|
| Comparator Agent |
Injection Neostigmine 0.05mg/Kg
at end of surgery before extubation |
Dosage : 0.05mg/kg body weight
Route : Intravenous
Duration : over 3minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Elective thoracic surgeries
Patients between 18years to 60years
Patients giving consent for study
|
|
| ExclusionCriteria |
| Details |
Patients with severe hepatic, renal, endocrine and cardiac dysfunction
Pregnant and lactating patients
Patient not willing to participate in study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effective reversal of neuromuscular blockade in thoracic surgery using sugammadex in comparison to neostigmine |
At start of reversal , 2 mins , 4 mins , 6 mins , 8 mins, 10 mins , 1 hour , 6 hours post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess haemodynamic changes and residual muscle weakness |
At start of reversal , 2 mins , 4 mins , 6 mins , 8 mins, 10 mins , 1 hour , 6 hours post extubation |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/12/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Neuromuscular blocking
drugs are considered essential because they can facilitate airway
instrumentation and improve surgical conditions. Residual neuromuscular
block is associated with upper airway obstruction, hypoxaemia,atelectasis and pneumonia.Furthermore, even
low levels of neuromuscular block (train-of-four [TOF] ratio <0.9 or <0.95)
in healthy volunteers not exposed to anaesthesia or surgery was associated with
pharyngeal and laryngeal dysfunction, and depressed hypoxic ventilatory
drive.Sugammadex is a modified gamma cyclodextrin, a selective binding agent
that antagonizes neuromuscular blockade produced by amino steroid
non-depolarizing muscle relaxants like rocuronium and vecuronium. Compared to
acetylcholinesterase inhibitors like neostigmine , sugammadex is associated with a faster reversal of
neuromuscular blockade. Patients undergoing thoracic surgeries require a deeper
level of neuromuscular blockade to prevent diaphragmatic movement from
interfering with the procedure and hence are at high risk of incomplete
neuromuscular recovery and associated complications.Patient will be taken into OT , monitors
attached , vital parameters like heart rate , SPO2 , Mean arterial
pressure and blood pressure will be monitored. Hemodynamic changes at the time of
reversal and time taken for emergence
from anaesthesia and effectiveness of reversal post administration of
Sugammadex ( 1.8 – 4.4mg/kg) will be assessed. |