| CTRI Number |
CTRI/2023/11/060300 [Registered on: 28/11/2023] Trial Registered Prospectively |
| Last Modified On: |
28/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
tendency of vomiting with two different drugs who undergo breast surgery. |
|
Scientific Title of Study
|
Effects of sugammadex versus neostigmine on postoperative nausea and vomiting after general anesthesia in patients undergoing breast surgery : A Randomized Clinical 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 Bibha Kumari |
| Designation |
Associate professor |
| Affiliation |
Indira Gandhi institute of medical sciences |
| Address |
Department of Anesthesiology and CCM ,Ward block First floor, IGIMS Patna
Patna
BIHAR
800014
India |
| Phone |
8252410069 |
| Fax |
|
| Email |
drbibha98aditi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarthak Misra |
| Designation |
Md Anaesthesia trainee |
| Affiliation |
Indira Gandhi institute of medical sciences |
| Address |
Department of Anesthesiology and CCM, Ward block First floor floor, IGIMS Patna
Patna
BIHAR
800014
India |
| Phone |
8210641979 |
| Fax |
|
| Email |
drsarthakmisra2021@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarthak Misra |
| Designation |
Md Anaesthesia trainee |
| Affiliation |
Indira Gandhi institute of medical sciences |
| Address |
Department of Anesthesiology and CCM, Ward block First floor floor, IGIMS Patna
BIHAR
800014
India |
| Phone |
8210641979 |
| Fax |
|
| Email |
drsarthakmisra2021@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and CCM Ward block First floor,Indira Gandhi institute of medical sciences sheikhpura Patna |
|
|
Primary Sponsor
|
| Name |
Dr Bibha Kumari |
| Address |
Indira Gandhi institute of medical sciences sheikhpura Patna |
| 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 Sarthak Misra |
Indira Gandhi institute of medical sciences |
State cancer institute Ot and icu complex, room no 356,357 3rd floor, state cancer institute, Near emergency and trauma, Indira Gandhi institute of medical sciences sheikhpura Patna
Patna
BIHAR |
8210641979
drsarthakmisra2021@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, IGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neostgimine |
Effect of nausea and vomiting after giving neostgimine in other group till 12 hours post operative. |
| Intervention |
Sugammadex |
effect of nausea and vomiting will be seen after sugammadex 2mg per kg till 12 hours post operative. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients willing to participate.
2.Patients 18-70 years of age.
3.ASA grade 1-4 patients.
4.Breast surgery requiring General Anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1.Patients with history of PONV
2.Impaired renal function
3.Requiring postoperative ventilation
4.Allergic to any study drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the incidence of PONV in patients undergoing reversal with sugammadex versus Neostigmine after general anaesthesia in breast surgery.
|
8 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses the postoperative need of anti-emetics and respiratory complications i.e. laryngospasm, bronchospasm & sore throat. |
8 months |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2024 |
| Date of Study Completion (India) |
31/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsarthakmisra2021@gmail.com].
- For how long will this data be available start date provided 31-10-2023 and end date provided 31-10-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Sugammadex is a selective gamma-cyclodextrin drug that terminates the action of muscle paralysis by encapsulating aminosteroid non-depolarizing muscle relaxant. It is a fast-onset drug without the muscarinic side effects of neostigmine. The well-known side effects of sugammadex were nausea and vomiting but these side effects had been shown to be well-tolerated in adult patients . A meta-analysis involving 17 randomized clinical trials that recruited 1,553 patients were unable to conclusively confirm any evidence for the differences in PONV effects between sugammadex and neostigmine. Due to these findings, we will be conducting this study with the aim of comparing the PONV effects when neuromuscular blockade was antagonized with sugammadex compared to neostigmine–atropine combination after abdomen surgery in oncological patients undergoing general anaesthesia.
|