| CTRI Number |
CTRI/2024/08/071849 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the two drugs sugammadex and neostigmine in reversing the patient , who is paralysed by vecuronium |
|
Scientific Title of Study
|
Comparison of sugammadex and neostigmine for reversal of vecuronium induced neuromuscular blockade in elderly patients |
| 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 GUNDA RAVI SHANKER REDDY |
| Designation |
Post graduate student |
| Affiliation |
Institute of medical sciences, SUM hospital |
| Address |
K8 Kalinganagar, Kalinganagar, Bhubaneswar, Odisha , india 751003
Khordha
ORISSA
751003
India |
| Phone |
7207028236 |
| Fax |
|
| Email |
ravishanker.52295@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SWASTIKA SWARO |
| Designation |
Professor |
| Affiliation |
Institute of medical sciences, SUM hospital |
| Address |
Department of Anesthesiology,IMS &SUM hospital,Siksha O Anusandham University,Bhubaneswar,khorda
Khordha
ORISSA
751003
India |
| Phone |
9861628628 |
| Fax |
|
| Email |
drswastika81@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GUNDA RAVI SHANKER REDDY |
| Designation |
Post graduate student |
| Affiliation |
Institute of medical sciences, SUM hospital |
| Address |
K8 Kalinganagar, Kalinganagar, Bhubaneswar, Odisha , india 751003
Khordha
ORISSA
751003
India |
| Phone |
7207028236 |
| Fax |
|
| Email |
ravishanker.52295@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS & SUM hospital, Khordha District, Bhubaneswar, Odisha 751003 |
|
|
Primary Sponsor
|
| Name |
Institute of medical sciences, SUM hospital |
| Address |
K8 Kalinganagar, Kalinganagar, Bhubaneswar, Odisha , india , 751003 |
| Type of Sponsor |
Private 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 GUNDA RAVI SHANKER REDDY |
Institute of medical sciences and sum hospital,Siksha O Anusandhan. |
Department of Anaesthesiology, institute of medical sciences and sum hospital, K8 Kalinganagar, Kalinganagar, Bhubaneswar, Odisha, 751003
Khordha
ORISSA |
7207028236
ravishanker.52295@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee , institute of medical sciences, SUM hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neostigmine |
Neostigmine will be given as 50 micro grams per kg through intravenous administration after completion of surgery, given only once.when train of four count is 2 , neostigmine 50 micro grams per kg is given and look for train of four count greater than 0.9 and the time is noted. |
| Intervention |
Sugammadex |
Sugammadex 2mg/kg body weight given intravenously after the completion of surgery,given only once as a muscle relaxant reversal.When Train of four count is 2, sugamadex 2mg/kg is given intravenously and look for Train of four count is greater than 0.9, and the time is noted. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgeries of age greater than 60 years and patients of ASA 1 and ASA 2 |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to give consent for the study, patient known allergic to narcotics, muscle relaxants, or other medication used during general anaesthesia, patients with anticipation of difficult airway, patients on drugs which are known to interact with neuromuscular blocking drugs, patients with significant renal dysfunction, patients who are known or suspected neuromuscular disorders |
|
|
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 |
| To determine the time taken from start of study drug injection to train of four 0.9 ratio |
Check train of four count every twenty minutes for one hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Look for other adverse effects of the drug such as nausea, vomiting, altered taste |
Check for every twenty minutes for one hour |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
15/08/2024 |
| 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="6"
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
|
In this study 96 elderly patients (age >60 years) posted for elective surgeries requiring general anesthesia will be included. After taking written informed consent, patients will be randomized into two groups (group A (n=48) and group B (n=48)).
General anaesthesia will be started with preoxygenation with 100% O2 for over 3 minutes. Premeditation, such as Glycopyrrolate(0.2mg), midazolam(1mg) and fentanyl(2mcg/kg) will be given.Then induction will be started by giving titrated doses of propofol (1.5-2 mg/kg).
A single bolus dose of vecuronium (0.1 mg/kg) is given, then intubation is done at TOF count 0(zero). Maintenance of anaesthesia is by giving isoflurane, oxygen and/or nitrous oxide.
Maintenance doses of vecuronium (0.02 mg/kg) will be administered as needed at reappearance of the second twitch (T2 ) on the TOF monitor or if clinically required.
At the end of surgery after reappearance of T3, either sugammadex 2 mg/kg or neostigmine 50ug/kg plus glycopyrrolate 10 ug/kg will be administered in a randomized order as an IV bolus within 10s.
Immediately after tracheal extubation, we will note the time to get TOF ratio 0.9. Then patient will be shifted to PACU(post anaesthesia care unit).
In PACU for every 20 minutes upto one hour we will observe for 5 second head lift, level of consciousness and train of four ratio(TOF) to check for any PORC( postoperative residual curarization).
Also any residual side effects like nausea ,vomiting, headache, dry mouth, altered taste, bradycardia will be noted.
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