| CTRI Number |
CTRI/2021/04/032750 [Registered on: 12/04/2021] Trial Registered Prospectively |
| Last Modified On: |
16/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study comparing two different combination of drugs for preventing vomiting after surgery. |
|
Scientific Title of Study
|
Efficacy of combining midazolam vs dexamethasone with ondansetron for prevention of Postoperative Nausea and Vomiting among women undergoing emetogenic surgeries - A randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yashaswini H Raya |
| Designation |
DNB Resident |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Bangalore Baptist Hospital,
Department of Anaesthesia,
First floor,
Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka
Bangalore
KARNATAKA
560024
India |
| Phone |
9886031472 |
| Fax |
|
| Email |
yashaswini.39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya P |
| Designation |
Senior consultant |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Bangalore Baptist Hospital,
Department of Anaesthesia,
First floor,
Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka
Bangalore
KARNATAKA
560024
India |
| Phone |
9886031472 |
| Fax |
|
| Email |
drpriyagdoc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashaswini H Raya |
| Designation |
DNB Resident |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Bangalore Baptist Hospital,
Department of Anaesthesia,
First floor,
Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka
Bangalore
KARNATAKA
560024
India |
| Phone |
9886031472 |
| Fax |
|
| Email |
yashaswini.39@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Baptist Hospital,
Bellary road,
Vinayakanagar,
Hebbal,
Bengaluru , Karnataka - 560024 |
|
|
Primary Sponsor
|
| Name |
Bangalore Baptist hospital |
| Address |
Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka 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 |
| Yashaswini h raya |
Bangalore Baptist Hospital |
Bangalore Baptist Hospital,
Department of Anaesthesia ,
First floor,
Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka 560024
Bangalore
KARNATAKA |
9886031472
yashaswini.39@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore baptist hospital |
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 |
DEXAMETHASONE |
This group will receive single dose of 0.1mg/kg IV of Inj. Dexamethasone after induction.30 minutes prior to extubation, single dose of Inj. Ondansetron 0.1mg/kg IV will be given |
| Intervention |
MIDAZOLAM |
This group will receive single dose of 0.04 mg/kg IV of Inj. Midazolam after induction .30 minutes prior to extubation,single dose of Inj. Ondansetron 0.1mg/kg IV will be given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Laparoscopic surgeries
Middle ear surgeries
Gynaecological surgeries
Breast surgeries
Cholecystecomies
BMI <34.9 kg/m2
|
|
| ExclusionCriteria |
| Details |
Smokers
Pregnant/lactating women
Use of nitrous oxide intraoperatively
Patients having history of motion sickness/ PONV
Patients on chronic steroid therapy
Patients on chronic opiod analgesics
Patients on preoperative chemotherapy
Patients who receive antiemetic/steroid 24 hrs prior to commencement of study
Patients suffering from diabetes mellitus with autonomic neuropathy, intestinal obstruction, hiatus hernia, hepatic and renal diseases
Patients with neurological diseases/ Neuromuscular diseases
Patients with prolonged QTC interval
Patients on CNS depressant drugs
Patients with psychiatric illness or cognitive impairment
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of Midazolam and Ondansetron Vs Dexamethasone and Ondansetron in prophylaxis of Post operative Nausea Vomiting in female patients undergoing emetogenic surgeries. |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Total dose of rescue antiemetic required
2.Total episodes of Nausea and Vomiting
3.Sedation score postoperatively |
1hr , 6hr , 12 hr |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
06/03/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postoperative nausea and vomiting (PONV) occurs in 20–30% of surgeries in the general population and in up to 70% of high risk patients within the first 24 hours after surgery. Routinely, the simplified risk score by Apfel et al is used to predict the risk of PONV in adult patients. The strongest predictive factors for PONV are female sex, non-smoking status, history of PONV or motion sickness and postoperative use of opioids.Surgical procedures such as cholecystectomy, gynaecological surgery, breast surgeries, middle ear surgeries and laparoscopic approach are associated with a higher incidence of PONV when compared with general surgery as a reference group and such surgeries are now considered as independent risk factor for PONV. In this study we are considering 2 risk factors – Female gender and Surgical risk factor ie. type of surgery. Combination therapy for PONV prophylaxis is preferable to using a single drug alone6,4. Apfel et al. demonstrated that the effects of antiemetics acting on different receptors are additive. Therefore adults at moderate and high risk for PONV should receive combination therapy with drugs from different classes.
In this study we aim to compare the efficacy of midazolam when combined with ondansetron, against the most widely used combination of dexamethasone and ondansetron.
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