| CTRI Number |
CTRI/2024/08/072352 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Conservative strategy for preventing nausea and vomiting after surgery in low-risk patients |
|
Scientific Title of Study
|
Efficacy of a restrictive anti-emetic strategy in patients with low risk of postoperative nausea and vomiting (PONV)- 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 CHAITRA V |
| Designation |
Assistant Professor |
| Affiliation |
Dr Chandramma Dayanand Sagar Institute of Medical Science & Research |
| Address |
CDSIMER Department of Anaesthesia Harohalli Ramanagar
Bangalore Rural KARNATAKA 562112 India |
| Phone |
9113518096 |
| Fax |
|
| Email |
chaitra1591@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR CHAITRA V |
| Designation |
Assistant Professor |
| Affiliation |
Dr Chandramma Dayanand Sagar Institute of Medical Science & Research |
| Address |
CDSIMER Department of Anaesthesia Harohalli Ramanagar
Bangalore Rural KARNATAKA 562112 India |
| Phone |
9113518096 |
| Fax |
|
| Email |
chaitra1591@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR CHAITRA V |
| Designation |
Assistant Professor |
| Affiliation |
Dr Chandramma Dayanand Sagar Institute of Medical Science & Research |
| Address |
CDSIMER Department of Anaesthesia Harohalli Ramanagar
Bangalore Rural KARNATAKA 562112 India |
| Phone |
9113518096 |
| Fax |
|
| Email |
chaitra1591@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr chandramma Dayanand Sagar Institute of Medical Education and Research , Devarakaggalahalli, Harohalli, Kanakapura Road, Karnataka - 562112 |
|
|
Primary Sponsor
|
| Name |
Dr Chandramma Dayananda Sagar Institute of Medical Education and Research |
| Address |
Devarakaggalahalli,Harohalli, Ramanagar, Kanakapura Road-562112 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Chaitra V |
Dr Chandramma Dayananda Sagar Institue of Medical Education and Research |
Department of Anesthesiology , Pre- operative room Bangalore Rural KARNATAKA |
9113518096
chaitra1591@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CDSIMER-IEC |
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 |
| Intervention |
ondansetron 4mg IV |
ondansetron 4mg IV |
| Comparator Agent |
Inj ondansetron and Inj Dexamethasone |
Inj ondansetron 4mg IV and Inj Dexamethasone 8 mg IV is compared with Inj ondansetron 4 mg IV prophylactically 30mins prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. patients with APFEL score 2or less preoperatively
2. duration of surgery less than 60 minutes
3. surgeries under spinal/regional/ local anaesthesia |
|
| ExclusionCriteria |
| Details |
surgeries with high risk of PONV like middle ear surgeries, laparotomy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of PONV in both groups in first 24 hours after surgery. |
1) patients will be monitored for 24 hrs after surgery .
2)duration of study is 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need for rescue antiemetics in 24 hours |
1) patients will be monitored for 24 hrs after surgery .
2)duration of study is 1 year |
|
|
Target Sample Size
|
Total Sample Size="640" Sample Size from India="640"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
26/08/2024 |
| 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="0" 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
|
Nausea and vomiting are one of the most frequently encountered symptoms in patients who have undergone a surgery.They can be especially distressing to the patient and hamper a speedy recovery, more so in case of day care procedures. Post operative Nausea and Vomiting or PONV as it is frequently referred to as, is a very important factor in the overall patient satisfaction in the hospital.The estimated incidence of PONV is around 30% in the overall surgical population and can be as high as 80% in high risk cohorts.The occurrence of PONV is also associated with increased length of PACU stay and increased health care costs.Hence, reducing the incidence of PONV should be a constant strife for the anaesthesiologist. The risk factors for an increased risk of PONV can be classified as patient factors like female sex, young age, non -smokers and a history of motion sickness/PONV and procedural factors like duration of anaesthesia, use of inhalational anaesthetics and nitrous oxide, General anaesthesia and use of post operative opioids. Apfel and colleagues devised a scoring system to risk stratify patients as high or low risk for PONV. The ‘Apfel Score’ includes female gender, non-smoker, history of PONV or motion sickness and post operative use of opioids, with a higher score meaning a higher chance of the patient experiencing PONV. Koivuranta score includes the risk factors of Apfel score along with duration of surgery > 60 minutes. The fourth consensus guidelines for the prevention and management of PONV was published in 2020 under the auspices of the American Society of Enhanced Recovery and Society for Ambulatory Anaesthesia. This is a comprehensive document for a clinician to practice in the perioperative arena. As per the consensus guidelines a multimodal therapy is advocated in patients to prevent PONV, with two different classes of anti-emetics in low risk and three or more different classes of anti-emetics in case of high risk patients. According to the fourth consensus guidelines for the management of PONV ‘there are very few studies directly comparing the efficacy of a risk-based “restrictive†antiemetic prophylaxis approach to a more liberal multimodal antiemetic prophylaxis approach’ They also state that direct comparisons of different combination therapies of anti-emetics is lacking and any evidence in that regard would prove invaluable. | |