| CTRI Number |
CTRI/2025/04/085076 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effects of sugammadex versus neostigmine on postoperative lung complications. |
|
Scientific Title of Study
|
The effects of sugammadex versus neostigmine on postoperative respiratory complications. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poornima.R |
| Designation |
Postgraduate |
| Affiliation |
Madurai medical college |
| Address |
Room no: 107
Madurai medical college
Madurai.
Madurai
TAMIL NADU
625020
India |
| Phone |
9600469186 |
| Fax |
|
| Email |
poorni.zennadianz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Poornima.R |
| Designation |
Postgraduate |
| Affiliation |
Madurai medical college |
| Address |
Room no:218,
Institute of anaesthesiology
Madurai medical college
Madurai
TAMIL NADU
625020
India |
| Phone |
9600469186 |
| Fax |
|
| Email |
poorni.zennadianz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poornima.R |
| Designation |
Postgraduate |
| Affiliation |
Madurai medical college |
| Address |
Room no:217
Institute of anaesthesiology
Madurai medical college
Madurai.
TAMIL NADU
625020
India |
| Phone |
9600469186 |
| Fax |
|
| Email |
poorni.zennadianz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institite of anaesthesiology
Madurai medical college
Madurai.
Tamil nadu - 625020
India. |
|
|
Primary Sponsor
|
| Name |
Dr Kalyanasundaram |
| Address |
Director,
Institute of anaesthesiology
Madurai medical college
Madurai,
tamilnadu 625020
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 Poornima |
Madurai medical college |
OT No 4
Institute of anaesthesiology
Madurai medical college
Madurai , Tamilnadu 625020
Madurai
TAMIL NADU |
9600469186
poorni.zennadianz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee madurai medical college govt rajaji hospuital , Madurai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dr Poornima |
Institute of anaesthesiology
Madurai medical college
Madurai,
Tamil nadu 625020 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2
Patients undergoing elective surgery under general anaesthesia with duration of less than 4 hours. |
|
| ExclusionCriteria |
| Details |
lack of consent from patient
preoperative respiratory failure
preoperative tracheostomy
pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
post extubation oxygen saturation
tOf ratio
clinical signs of recovery |
post extubation oxygen saturation for 1hour postoperative period
tOf ratio for one hour postoperative period
clinical signs of recovery for one hour postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| respiratory failure requiring non invasive ventilation or tracheal reintubation |
till 7 days postoperative |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2 |
|
Date of First Enrollment (India)
|
28/04/2025 |
| 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 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
|
Reversing neuromuscular
blockade with sugammadex can eliminate residual paralysis, which has been
associated with postoperative respiratory complications. This study was planned
with an aim to study and compare the effects of sugammadex versus neostigmine
on postoperative respiratory complications
|