UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013466 |
|---|---|
| Receipt number | R000015720 |
| Scientific Title | Effects of intravenous ondansetrion on preventing hypotension after induction of anesthesia in eldery patients: A randomized placebo controlled clinical trial |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2014/10/02 16:23:58 |
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Basic information
Public title
Effects of intravenous ondansetrion on preventing hypotension after induction of anesthesia in eldery patients: A randomized placebo controlled clinical trial
Acronym
Ondansetron for prevention of hypotension
Scientific Title
Effects of intravenous ondansetrion on preventing hypotension after induction of anesthesia in eldery patients: A randomized placebo controlled clinical trial
Scientific Title:Acronym
Ondansetron for prevention of hypotension
Region
| Asia(except Japan) |
Condition
Condition
Ondensetron's inhibition of serotinine receptors may play a role in preventing some types of hypotention specially those due to serotonine receptor activation such as Bezold Jarrish reflex. Ondansetron prevents post-spinal anesthesia hypotention in C-Section deliveries
Classification by specialty
| Medicine in general | Cardiology | Geriatrics |
| Surgery in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing blood pressure, heart rate and SpO2 between ondansetron and placebo group before and after induction of anesthesia and after tracheal intubation. Comparing ETCO2 after tracheal intubation between ondansetron and placebo group
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
rates of hypotention after induction of general anesthesia
Key secondary outcomes
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 not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous Ondansetron 0.05 mg/kg
Interventions/Control_2
Equivalent volume of normal saline
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
| 65 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Older than 65 years
ASA I, II
Key exclusion criteria
Sensitivity to ondansetron
Resting bradycardia (< 60 bpm)
History of SSRI usage
Congestive Heart Failure
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mahmoud Saghaei |
Organization
Isfahan University of Medical Sciences
Division name
Department of Anesthesia
Zip code
Address
Al-Zahra Medical Center
TEL
+81-983116249031
mahmood.saghaei@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mahmoud Saghaei |
Organization
Isfahan University of Medical Sciences
Division name
Department of Anesthesia
Zip code
Address
Al-Zahra Medical Center
TEL
+81-983116249031
Homepage URL
http://www.saghaei.net/
mahmood.saghaei@gmail.com
Sponsor or person
Institute
Department of Anesthesia, Isfahan University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Research Department, Isfahan University of Medical Sciences
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Iran
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Al-Zahra Medical Center, Al-Zahra hospital, Anesthesia Section
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 05 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 19 | Day |
Last modified on
| 2014 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015720
