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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013466
Receipt No. 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

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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
Email 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/
Email mahmood.saghaei@gmail.com

Sponsor
Institute Department of Anesthesia, Isfahan University of Medical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015720

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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