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
|
|
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
|
|
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. |