UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050665 |
|---|---|
| Receipt number | R000057723 |
| Scientific Title | A STUDY TO ASSESS THE EFFECT OF PRETREATMENT WITH INTRAVENOUS PALONOSETRON IN PREVENTING PAIN ON PROPOFOL INJECTION |
| Date of disclosure of the study information | 2023/03/23 |
| Last modified on | 2023/03/23 23:31:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to assess the effect of palonosetron in preventing propofol pain
Acronym
A study to evaluate the effect of palonosetron in preventing propofol pain
Scientific Title
A STUDY TO ASSESS THE EFFECT OF PRETREATMENT WITH INTRAVENOUS PALONOSETRON IN PREVENTING PAIN ON PROPOFOL INJECTION
Scientific Title:Acronym
A study to evaluate effect of intravenous palonosetron in preventing pain on propofol injection
Region
| Asia(except Japan) |
Condition
Condition
ASA 1 and ASA 2 patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of pre-treatment with intravenous palonosetron in preventing pain on propofol injection.
To evaluate the safety profile associated with the use of Palonosetron.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the effect of pre-treatment with intravenous palonosetron in preventing pain on propofol injection.
Key secondary outcomes
To evaluate the safety profile associated with the use of Palonosetron.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Group P - received palonosetron 0.075mg (2ml) intravenous route before propofol injection
Interventions/Control_2
Group S - received normal saline (2ml) intravenous route
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient who give written informed consent.
Patients aged 18-60 yrs.
Patients scheduled for elective surgery under general anaesthesia.
Patients with ASA (American Society of Anaesthesiologists) grade I & II
Key exclusion criteria
Patients refusing to participate in the study.
Patients inability to verbally express the severity of pain.
Patients with ischemic heart disease, previous myocardial infarction, congestive heart failure, congenital long QT syndrome.
Patients with electrolyte abnormalities.
Patients with hepatic and renal dysfunction.
Patients with chronic alcohol abuse and patients on antipsychotic drugs
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nethra |
| Middle name | |
| Last name | S S |
Organization
Bangalore Medical College and Research Institute
Division name
Department of Anaesthesiology
Zip code
560002
Address
Fort, K.R. Road Bangalore - 560 002 Karnataka, India
TEL
08026700810
nethra.surhonne@gmail.com
Public contact
Name of contact person
| 1st name | Chaithali |
| Middle name | |
| Last name | Hebri |
Organization
Rajarajeswari Medical College and Hospital
Division name
Department of Anaesthesiology
Zip code
560074
Address
No.202, Kambipura, Mysore Road, Bengaluru-560 074.
TEL
7975454808
Homepage URL
chaithali.hebri@gmail.com
Sponsor or person
Institute
Bangalore Medical College and Research Institute
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bangalore Medical College and Research Institute
Address
Fort, K.R. Road Bangalore - 560 002 Karnataka, India
Tel
08026700810
chaithali.hebri@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
will be entered later
Publication of results
Unpublished
Result
URL related to results and publications
will be entered later
Number of participants that the trial has enrolled
100
Results
100 patients.
Results date posted
| 2023 | Year | 03 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Demographic characteristics, duration of surgery and the type of surgeries in both groups were comparable
Participant flow
100 patients of either sex were randomly allocated (computer generated randomisation) to two different groups of 50 each as described below
Group P received palonosetron 0.075mg (2ml) intravenous route
Group S received normal saline (2ml) intravenous route
Adverse events
QTc interval ,tinnitus was monitored.
Outcome measures
Assessment for degree of pain using McCrirrick and Hunter Pain Scale for propofol injection in both groups.
QTc interval will be monitored before premedication, pre-treatment after induction and then every half hrly till the end of the surgery
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 23 | Day |
Last modified on
| 2023 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057723
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
