| CTRI Number |
CTRI/2022/10/046442 [Registered on: 13/10/2022] Trial Registered Prospectively |
| Last Modified On: |
01/04/2023 |
| 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
|
A study comparing ability of palanosetron and ondansetron with dexamethasone in preventing post operative vomiting after laparascopic surgeries |
|
Scientific Title of Study
|
A Comparative study on efficacy of intravenous palonosetron versus ondansetron and dexamethasone combination as a prophylaxis for prevention of postoperative nausea and vomiting after laparoscopic surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak krishnan R |
| Designation |
Postgraduate |
| Affiliation |
Sri Venkateswaraa medical college hospital and research center |
| Address |
Department of anaesthesiology and critical care
Sri venkateshwaraa medical college hospital and Research center
13-A Pondy Villupuram main road,ariyur,Puducherry-605102
Pondicherry
PONDICHERRY
605102
India |
| Phone |
7200040440 |
| Fax |
|
| Email |
dr.deepakkrishnan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ArthiA |
| Designation |
Associate professor |
| Affiliation |
Sri Venkateswaraa medical college hospital and research center |
| Address |
Department of anaesthesiology and critical care
Sri venkateshwaraa medical college hospital and Research center
13-A Pondy Villupuram mainroad Ariyur Puducherry 605102
Pondicherry
PONDICHERRY
605102
India |
| Phone |
7895683205 |
| Fax |
|
| Email |
drarthimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ArthiA |
| Designation |
Associate professor |
| Affiliation |
Sri Venkateswaraa medical college hospital and research center |
| Address |
Department of anaesthesiology and critical care
Sri venkateshwaraa medical college and Research center
13-A Pondy Villupuram mainroad ariyur Puducherry-605102
Pondicherry
PONDICHERRY
605102
India |
| Phone |
7895683205 |
| Fax |
|
| Email |
drarthimd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswaraa medical college hospital and research center |
|
|
Primary Sponsor
|
| Name |
Sri Venkateswaraa medical college hospital and research center |
| Address |
Sri Venkateswaraa medical college hospital and research center,Ariyur,puduchery |
| 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 |
| Deepak krishnan |
Sri Venkateshwaraa medical college hospital and research center |
Department of anaesthesiology SVMCH&RC
Ariyur
Puducherry-605102
Pondicherry
PONDICHERRY |
7200040440
dr.deepakkrishnan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
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 |
Ondansetron with dexamethasone |
Ondansetron 4mg with dexamethasone 4mg i.v administered 3minutes before induction and incidence of Post operative nausea and vomiting will be observed over 48hours |
| Intervention |
Palonosetron |
Palanosetron 0.075mg i.vadministered 3minutes before induction and incidence of postoperative nausea and vomiting will be observed for 48hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who give valid inform consent and willing to participate in the study
1) ASA grade I/II patients
2) age group of 18 to 60 years scheduled to undergo elective laparoscopic surgeries, under
general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Patient refusing to participate in the study
1) Any contraindication to the use of drug
2)BMI >35kg/m2
3) ASA III or more,
4) emergency procedure
5) Pregnant and lactating patients
• Patients with history of motion sickness
• Patients on steroid therapy, antiemetics or on treatment with other medication known
to produce nausea and vomiting |
|
|
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 |
| asses incidence of post operative nausea and vomitting for 48 hours |
0mins,30mins,60mins,2hrs,4hrs,6hrs,8hrs,10hrs,12hrs,16hrs,20hrs,24hrs,36hrs,48hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| requirement of rescue anti emetic |
48 hours post operative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to compare the efficacy of Palonosetron versus ondansetron and dexamethasone combination as prophylaxis for prevention of postoperative nausea and vomiting after laparoscopic surgeries. This study will be done after CTRI registry and clearance. Subject
will be recruited based on inclusion and exclusion criteria. A written informed consent will be
obtained from all the subjects.
A detailed medical history will be obtained from all the subjects. To do this study patients will be
asked to follow some prerequisites according to standard anesthetic protocol. On the day of
surgery, Patient will be shifted to OT-complex and an IV cannula will be inserted in patient hand,
through which the study drug will be given.
These drugs injected intravenously will anaesthetize and study drug will prevent nausea and
vomiting intraoperatively and postoperatively. After surgery patient will be shifted to recovery,
continuously monitored, and any complications occurring during this period will also be treated
accordingly.
If the patient decide to participate in this research, He /She will be placed in the group according to
randomization and patient may get either of the drugs during surgical procedure, if the drugs fail
rescue antiemetic will be given and it will be noted. Patients will be followed up in the post operative ward for first 48hours. |