UMIN-CTR Clinical Trial

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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