| CTRI Number |
CTRI/2025/08/093476 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Sugammadex in patients on ventilator support |
|
Scientific Title of Study
|
To study the clinical characteristics and duration of ventilator support in patients who received sugammadex during their ICU stay |
| 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 Amarja Havaldar |
| Designation |
Professor |
| Affiliation |
St Johns medical college |
| Address |
Department of Critical Care medicine, St Johns medical college Hospital
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
09036082112 |
| Fax |
|
| Email |
amarjahavaldar@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amarja Havaldar |
| Designation |
Professor |
| Affiliation |
St Johns medical college |
| Address |
Department of Critical Care medicine, St Johns medical college Hospital
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
09036082112 |
| Fax |
|
| Email |
amarjahavaldar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amarja Havaldar |
| Designation |
Professor |
| Affiliation |
St Johns medical college |
| Address |
Department of Critical Care medicine, St Johns medical college Hospital
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
09036082112 |
| Fax |
|
| Email |
amarjahavaldar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Critical Care medicine St Johns Medical College Hospital Bangalore KARNATAKA 560034 India |
|
|
Primary Sponsor
|
| Name |
Dr Amarja Ashok Havaldar |
| Address |
Department of Critical care medicine St Johns medical college |
| Type of Sponsor |
Other [Self] |
|
|
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 Amarja Ashok Havaldar |
St Johns medical college Hospital |
Department of Critical Care medicine
Bangalore
KARNATAKA |
09036082112
amarjahavaldar@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St Johns medical college, Insitutioal Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z991||Dependence on respirator, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients on invasive mechanical ventilation
Patients received sugammadex
|
|
| ExclusionCriteria |
| Details |
Patients who have not received sugammadex will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of sugammadex on the duration of mechanical ventilation |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The length of ICU stay in patients who received sugammadex. |
1 week
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
10/09/2025 |
| 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
|
Sugamadex is a reversal agent used predominantly in perioperative settings. There are not enough studies looking at the use of this drug in the ICU. This study is a retrospective study evaluating the use of this drug in the ICU population. The primary outcome is the duration of ventilator days after the administration of the sugammadex. |