| CTRI Number |
CTRI/2024/06/069683 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of sugammadex versus neostigmine on respiratory muscle strength recovery after extubation. |
|
Scientific Title of Study
|
Comparative Evaluation of Sugammadex Versus Neostigmine on Recovery of Respiratory Muscle Strength in the Post Extubation Period. |
| 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 Sonia Saini |
| Designation |
Post Graduate Student |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Anaesthesiology
ESIC Medical College and Hospital
NH3 NIT Faridabad
HARYANA
Faridabad
HARYANA
121001
India |
| Phone |
8708286503 |
| Fax |
|
| Email |
soniasaini414@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Virmani |
| Designation |
HOD and Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Anaesthesiology
ESIC Medical College and Hospital NH3 NIT Faridabad
Haryana
Faridabad
HARYANA
121001
India |
| Phone |
9654959719 |
| Fax |
|
| Email |
rashmi.virmani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Sonia Saini |
| Designation |
Post Graduate Student |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Anaesthesiology
NH3 NIT Faridabad
ESIC MEDICAL COLLEGE AND HOSPITAL FARIDABAD
Haryana
Faridabad
HARYANA
121001
India |
| Phone |
08708396229 |
| Fax |
|
| Email |
soniasaini414@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical college and hospital
NH3 NIT Faridabad
India
121001 |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College and Hospital |
| Address |
ESIC Medical College and Hospital
Faridabad
Haryana 121001 |
| 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 Sonia Saini |
ESIC Medical college and Hospital NH3 NIT Faridabad |
Department of Anaesthesiology OT Complex, 3rd Floor
ESIC Medical College and Hospital
Faridabad
Haryana
Faridabad
HARYANA |
8708286503
soniasaini414@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee ESIC Medical College and Hospital Faridabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H701||Chronic mastoiditis, (2) ICD-10 Condition: H712||Cholesteatoma of mastoid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neostigmine |
I will compare the effect of Neostigmine (0.5 mg/kg) with Sugammadex ( 2mg/kg) on respiratory muscle strentgh in post extubation and 30 minutes after shifting in PACU |
| Intervention |
Sugammadex |
I will compare the effect Sugammadex (2mg/kg) with Neostigmine (0.5 mg/kg) on resoiratory muscle strength in post extubation period and 30 minutes after shifting in PACU |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologist (ASA) physical status 1 and 2 posted for surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Parturient or lactating women OR undergoing thoracic or abdominal surgery OR neuromuscular disease chronic obstructive pulmonary disease significant kidney and liver disease OR allergic to rocuronium neostigmine |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effect of sugammadex and neostigmine on difference in thickening fraction of internal oblique (TFIO) from baseline to TOFR more than or equal to 0.9 |
preoperative and in Post extubation at TOFR more than or equal to 0.9 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare change in TFIO and diaphragm excursion from baseline to 30 minutes in PACU in both groups |
30 minutes in PACU |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/07/2024 |
| 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="3"
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
|
i will do this study to compare the effect of sugammadex versus neostigmine on recovery of respiratory muscle strength by measuring thickening fraction of internal oblique muscle and diaphragm excursion at three point times preoperatively, post extubating and 30 minutes after shifted to PACU. My research question is whether sugammadex will enhance expiratory muscle strength recovery more than neostigmine in the immediate post extubating period. |