| CTRI Number |
CTRI/2025/04/085259 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the incidence of post operative nausea and vomiting using neostigmine and sugammadex as a reversal agent |
|
Scientific Title of Study
|
Efficacy of Sugammadex versus Neostigmine on post operative nausea and vomiting after general anaesthesia in adult patients: a randomised control trial |
| 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 Ratulbir Goyal |
| Designation |
Post Graduate Trainee |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
Kalinga Institute of Medical Sciences
Khordha
ORISSA
751024
India |
| Phone |
7008016886 |
| Fax |
|
| Email |
2387017@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ratulbir Goyal |
| Designation |
Post Graduate Trainee |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
Kalinga Institute of Medical Sciences
Khordha
ORISSA
751024
India |
| Phone |
7008016886 |
| Fax |
|
| Email |
2387017@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ratulbir Goyal |
| Designation |
Post Graduate Trainee |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
Kalinga Institute of Medical Sciences
Khordha
ORISSA
751024
India |
| Phone |
7008016886 |
| Fax |
|
| Email |
2387017@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute Of Medical Sciences Bhubaneswar District Khorda Odisha
pin-751024 |
| self |
|
|
Primary Sponsor
|
| Name |
DrRatulbir Goyal |
| Address |
Department Of Anesthesiology
Kalinga Institute of Medical Sciences, Bhubaneswar , District Khordha , Odisha
pin-751024 |
| 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 Ritesh Roy |
Pradyuman Bal Memorial Hospital & Kalinga Institute of Medical Sciences |
Department Of Anaesthesiology 3rd Floor Kalinga Institute of Medical Sciences
Khordha
ORISSA |
7008016886
drriteshroy@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kalinga Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MEDICAL AND SURGICAL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neostigmine as a Reversal Agent after General Anaesthesia |
Neostigmine 0.05mg/kg of body weight will be adminstered az reversal agent after general anesthesia followed bybwhich prophylactic Ondansetron 8mg/kg will be given. |
| Intervention |
Sugammadex as a Reversal Agent After General Anesthesia. |
Sugammadex 4mg/kg body weight will be given as reversal agent after surgery follwed by which prophylactic Ondansetron 8mg iv will be also given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All ASA-1 and ASA-2 patients not coming under exclusion criteria |
|
| ExclusionCriteria |
| Details |
Pregnancy and Breastfeeding Mothers
Neuromuscular Disorders
Significant Hepatic And Renal Impairement |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the Incidence of PONV between both the drugs within the first 24 hours of Post Operative period |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare the Clinical Parametres of Recovery |
1 HOUR |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
30/04/2025 |
| 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="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
|
NEOSTIGMINE AND GLYCOPYROLATE IN COMBINATION IS THE COMMON REVERSAL AGENT THAT IS USED . SUGAMMADEX CAN OFFER QUICKER AND BETTER RECOVERY AND DECREASED INCIDENCE OF POST OPERATIVE NAUSEA AND VOMITTING
|