| CTRI Number |
CTRI/2019/05/019171 [Registered on: 15/05/2019] Trial Registered Prospectively |
| Last Modified On: |
02/06/2020 |
| 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
|
Study to see whether the addition of a medicine to the routine medicine will help in preventing vomiting after breast surgeries |
|
Scientific Title of Study
|
A double blind randomized control study to compare the antiemetic efficacy of ondansetron versus ondansetron and dexamethasone combination in patients undergoing breast surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr APOORVA D S |
| Designation |
POSTGRADUATE IN SECONDARY DNB |
| Affiliation |
BANGALORE BAPTIST HOSPITAL |
| Address |
NO 1500, 25TH MAIN BANASHANKARI SECOND STAGE BANGALORE 70
BELLARY ROAD, VINAYAKANAGAR,HEBBAL, BANGALORE 560024
Bangalore
KARNATAKA
560070
India |
| Phone |
9902818132 |
| Fax |
|
| Email |
apoorvads07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr REENA R KADNI |
| Designation |
CONSULTANT ANAESTHESIOLOGIST |
| Affiliation |
BANGALORE BAPTIST HOSPITAL |
| Address |
MAYS QUARTERS NO 4 , BANGALORE BAPTIST HOSPITAL,BELLARY ROAD,VINAYAKANAGAR,HEBBAL BANGALORE-560024
Bellary road vinayakanagar,Hebbal, Bangalore 560024
Bangalore
KARNATAKA
560024
India |
| Phone |
8197201890 |
| Fax |
|
| Email |
docreena1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reena R Kadni |
| Designation |
CONSULTANT ANAESTHESIOLOGIST |
| Affiliation |
BANGALORE BAPTIST HOSPITAL |
| Address |
MAYS QUARTERS NO 4,BANGALORE BAPTIST HOSPITAL, BELLARY ROAD VINAYAKANAGAR, BANGALORE 560024
BELLARY ROAD,VINAYAKANAGAR ,HEBBAL, BANGALORE 560024
Bangalore
KARNATAKA
560024
India |
| Phone |
8197201890 |
| Fax |
|
| Email |
docreena1@gmail.com |
|
|
Source of Monetary or Material Support
|
| BANGALORE BAPTIST HOSPITAL, BELLARY ROAD ,VINAYAKANAGAR, HEBBAL,BANGALORE 560024 |
|
|
Primary Sponsor
|
| Name |
Bangalore Baptist Hospital |
| Address |
Bellary road vinayakanagar,Hebbal, Bangalore 560024 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 APOORVA D S |
BANGALORE BAPTIST HOSPITAL |
ROOM NO 44, DEPARTMENT OF ANAESTHESIA FIRST FLOOR,BELLARY ROAD, VINAYAKANAGAR, HEBBAL, BANGALORE 560024
Bangalore
KARNATAKA |
9902818132
apoorvads07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board Bangalore Baptist Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexamethasone |
group 2 receives 0.1mg/kg of dexamethasone plus 0.1 mg/kg of ondansetron |
| Intervention |
ondansetron |
Group 1: patients will receive 0.1mg/kg iv of Inj. Ondansetron. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
All females belonging to ASA I and II undergoing breaast surgeries |
|
| ExclusionCriteria |
| Details |
1.Patients on chronic steroid therapy ,
2.pregnant/lactating women,
3.patients having history of motion sickness
4.patients on preoperative chemotherapy ,
5.patients having received antiemetic ,steroid within 24hrs of surgery
6.patients suffering from diabetes mellitus, intestinal obstruction, hiatus hernia, hepatic and renal diseases
7.patients with prolonged QTC interval
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nausea and vomiting |
within 24hrs after breast surgeries. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the need for resscue antiemetic in 24hrs after breast surgery |
within 24hours |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/05/2019 |
| Date of Study Completion (India) |
19/11/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Serotonin (5 Hydroxy tryptamine) receptor antagonists like ondansetron are the most commonly used drug for the prevention and treatment of Post-Operative nausea and vomiting (PONV) in all surgeries. It has been found that there is a very high incidence of PONV in patients undergoing breast surgeries. It has been found that the glucocorticoid, dexamethasone is a very potent and long acting anti emetic and it also augments the antiemetic property of other drugs. Thus in our study we are comparing the efficacy of ondansetron alone or when used in combination with dexamethasone is better for preventing PONV and need for rescue antiemetic in patients undergoing breast surgeries. |