| CTRI Number |
CTRI/2025/03/083546 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A STUDY TO EVALUATE EFFICIENCY OF PALONOSETRON VS AMISULPRIDE FOR POST OPERATIVE NAUSEA AND VOMITING UNDER GENERAL ANAESTHESIA |
|
Scientific Title of Study
|
A comparative study to evaluate efficay, Of intravenous palonosetron vs amisulpride. For post operative nausea and vomiting under general anaesthesia - a randomised study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S BALASUBRAMANIAN |
| Designation |
Resiedent doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760
Vadodara GUJARAT 391760 India |
| Phone |
944349625 |
| Fax |
|
| Email |
balu94sm@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dinesh Chauhan |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760
Vadodara GUJARAT 391760 India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dinesh Chauhan |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760
Vadodara GUJARAT 391760 India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt.Bhikiben Kanjibai Shah Medical institiute and Research center,pipariya,waghodia,vadodara,gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, |
| Address |
Waghodiya, Pipariya, Vadodara, Gujarat, 391760 |
| Type of Sponsor |
Private medical college |
|
|
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 dinesh chauhan |
Department of anaesthesia Smt.Bhikhiben Kanjibhai Shah Medical Institute and Research Centre |
Smt.Bhikhiben Kanjibhai Shah Medical Institute and Research Centre,Pipariya,Waghodiya,Vadodara,Gujarat,India 391760 Vadodara GUJARAT |
9099014672
drdinesh77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sumandeep vidhyapeeth institutional ethical 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 |
| Intervention |
inj.palonosetran 0.075mg |
Group A will receive palonosetran 0.075mg iv 15 min before surgery |
| Comparator Agent |
inj.amisulpride 5mg |
Group B receive inj.amisulpride 5mg iv 15 min before surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Surgery to last at least 1 hour
2 Overnight stay
3 General anaesthesia
4 ASA I&II
5 At least one of the following Apfel et al’s risk factors for PONV:
6 Female sex
7 Non-smoking status
8 A prior history of PONV or motion sickness
9 Being expected to receive postoperative opioid analgesia |
|
| ExclusionCriteria |
| Details |
If any antihistaminic, continuous infusion of propofol or dexmedetomidine, steroids, any antiemetics is used 24 hours prior or post-surgery then the case will be not selected for the study.
Cardiac surgery
Intrathoracic
Transplant
CNS surgery
If required post-operative ventilation
Need a nasogastric tube in situ
Parkinsons disease
Pre-existing vestibular disorder
History of dizziness
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study efficacy and safety between intravenous PALONOSETRON and AMISULPRIDE to prevent post-operative nausea vomiting. |
patient will assed at 1st,2nd,6th,12th,24th hour intervels after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •to study efficacy and safety between intravenous PALONOSETRON and AMISULPRIDE to prevent post-operative nausea vomiting. |
• Efficacy was assessed during the 48 hours after administration of the study drug Episodes of emesis vomiting or retchingband the use of rescue medication were recorded. Nausea scored using a self-reported 11-point verbal scale where 0 represented no nausea and 10 was the worst nausea possible was assessed Predose at 5 15 and 30 minutes and 2 hours after administration of study medication Any nausea episodes spontaneously reported by the patient in the 48 hours was also scored and recorded. |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
10/04/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare antiemetic efficacy of intravenous
administration of Inj.palonosetron and Inj. amisulpride for post operative
nausea and vomiting under general anaesthesia.
OBJECTIVES is to study the complete response of
drugs i.e. no episodes of emesis and no use of rescue medication in first 24
hours after surgery or PONV and to observe the incidence of nausea, vomiting,
use of rescue medicine and any adverse events.
Inclusion criteria: Surgery to last at least 1-hour, Overnight
stay, General anaesthesia, ASA I&II and At least one of the
following Apfel et al
Risk factors for PONV Female sex, Non-smoking status, A
prior history of PONV or motion sickness and being expected to
receive postoperative opioid analgesia
Exclusion Criteria If any antihistaminic,
continuous infusion of propofol or dexmedetomidine, steroids, any
antiemetics is used 24 hours prior or post-surgery then the case will be not
selected for the study, Cardiac surgery, Intrathoracic, Transplant, CNS
surgery, If required post-operative ventilation, Need a nasogastric tube in
situ, Parkinson’s disease, Pre-existing vestibular disorder, History of
dizziness, Alcohol abuse, Cardiac arrhythmia, Epilepsy, Emergency surgery, ASA
III and above, Morbid obesity if weight greater than 120kg,Renal or liver
disease, Pregnancy, Hypersensitivity and Known allergy
We will be conducting this on 60 adults aged 18-65yrs
belonging to grade I and II of American Society of anaesthesiologists (ASA)
classification who will undergo operation under general anaesthesia. They will
be divided into 2 equal groups based on chit method.
Group A will receive palonosetran 0.075mg and Group B
receive 5mg amisulpride and. Each group will have 30 patients based on chit
method and the study drug will be administered by the consultant
anaesthesiologist present in the operation theatre there. Haemodynamic
parameters will be noted post-operatively at 0,2,6,8,12, 24, 48hours.Rescue
antiemetic will be given upon VRS of more than or equal to 4 score i.e.
moderate nausea in form of ondansetron 4 mg
Episodes of emesis (vomiting or retching) and use of
rescue medication will be recorded. Nausea (scored using a self-reported
11-point verbal scale, where 0 represented no nausea and 10 the worst nausea
possible) was assessed Predose and at 5, 15, and 30 minutes and 2 hours after
administration of study medication. Any nausea episodes spontaneously reported
by the patient in the 24-hour period will also be scored and recorded.
Site of Study Department of anaesthesiology,
Dhiraj Hospital, S.B.K.S. Medical Institute and research Centre, Piparia,
Waghodia, Vadodara from 2024-2025
Study Design Prospective observational study
Study Duration The study will be initiated after
obtaining permission from institutional ethics committee till the achievement
of the sample size or completion of time period of study whichever is earlier.
Numerical variables will be presented as mean &
standard deviation (SD) while categorical variables will be presented as
frequency and percentage. As regard to numerical variables; tests like unpaired
student-t test and/or ANNOVA will be used wherever appropriate for
between-groups comparisons, while for categorical variables; chi-square test
will be used. P value <0.05 will be considered statistically significant.
LIKELY OUTCOME/BENEFITS OF STUDY We will get to know
the efficacy of and safety of intravenous amisulpride as a sole agent
to prevent post-operative nausea vomiting, Early ambulation of the patient
and less stay in hospital and bed occupancy thus reducing economic burden. |