| CTRI Number |
CTRI/2019/09/021070 [Registered on: 05/09/2019] Trial Registered Prospectively |
| Last Modified On: |
04/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Palonosetron with Palonosetron and Dexamethasone in avaoiding Post-Operative Nausea and Vomiting in Female Patients Undergoing Laparoscopy surgery |
|
Scientific Title of Study
|
Comparison of Clinical Efficacy of Palonosetron with Palonosetron and Dexamethasone in prevention of Post-Operative Nausea and Vomiting in Female Patients Undergoing Laparoscopy Cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aashima Jain |
| Designation |
Primary Dnb Resident first year |
| Affiliation |
satguru partap singh hospitals, sherpur chowk, gt road ludhiana |
| Address |
SPS hospital , Anaesthesia department
SPS hospitals,Sherpur chowk
Ludhiana
PUNJAB
141003
India |
| Phone |
9815271382 |
| Fax |
|
| Email |
aashimajain11992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritul Mehta |
| Designation |
Senior Consultant |
| Affiliation |
satguru partap singh hospitals, sherpur chowk, gt road ludhiana |
| Address |
SPS hospitals, Anaesthesia Department
SPS hospitals,Anaesthesia department
Ludhiana
PUNJAB
141003
India |
| Phone |
|
| Fax |
|
| Email |
drRitulmehta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aashima Jain |
| Designation |
Primary Dnb Resident first year |
| Affiliation |
satguru partap singh hospitals, sherpur chowk, gt road ludhiana |
| Address |
SPS hospital , Anaesthesia Department
SPS hospitals,Sherpur chowk,GT road
Ludhiana
PUNJAB
141003
India |
| Phone |
9815271382 |
| Fax |
|
| Email |
aashimajain11992@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SPS Hospitals |
| Address |
satguru partap singh hospitals, Anaesthesia department, sherpur chowk gt road ludhiana |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Aashima Jain |
SPS Hospitals, Anaesthesia Department |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aashima Jain |
SPS Hospitals |
Anaesthesia Department second floor
Ludhiana
PUNJAB |
9815271382
aashimajain11992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee For Thesis |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj Palonosetron 75 mcg IV STAT |
Comparison between the efficacy of Palonosetron with Palonosetron and Dexamethasone in prevention of post-operative nausea and vomiting in female patients undergoing laparoscopy cholecystectomy.
Inj Palonosetron 75 mcg IV STAT
|
| Comparator Agent |
Inj Palonosetron 75mcg IV STAT and Inj Dexamethasone 8mg IV STAT |
Comparison between the efficacy of Palonosetron with Palonosetron and Dexamethasone in prevention of post-operative nausea and vomiting in female patients undergoing laparoscopy cholecystectomy. Inj Palonosetron 75mcg IV STAT and Inj Dexamethasone 8mg IV STAT |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Female Patients
Laproscopic Cholecystectomy
ASA grade 1 and 2
|
|
| ExclusionCriteria |
| Details |
History of DM
Psychiatric disorder
BMI more than 30kg/m2
Male Patients
ASA grade 3 and 4 |
|
|
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 |
| Incidence of Post Operative Nausea and Vomiting |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need of Rescue Anti-emetic |
24 hours |
Adverse effect of Inj Palonosetron
and Inj Dexamethasone |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
05/09/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of the study is to compare the clinical efficacy of Palonosetron with Palonosetron and Dexamethsone in prevention of post-opertative nausea and vomiting in female patients undergoing laproscopic cholecystectomy. total 120 ASA grade 1 and 2 patients were enrolled. Primary objective is to compare the incidence of post operative nausea and vomiting during first 24 hours and to compare the severity of nausea. Secondary objective is to identify the need of anti emetic , number of complete responders and to observe the incidence of adverse effects of Palonosetron and Dexamethsone. |