Protocol summary

Study aim
determination and comparing the effect of two different doses of ondansetron on heart rate , blood pressure and blood oxygen saturation variation in caesarian surgery under spinal anesthesia
Design
Randomised, controlled , parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an excel
Settings and conduct
This study is a randomized double-blind clinical trial that randomization will be done by usind random numbers. this study will be done in Beheshti Hospital.
Participants/Inclusion and exclusion criteria
Age between 18 to 45 years old ASA number 1 and 2 Patient is cesarian candida that term pregnancy Patient has no disease like hypertention Patient has no uncontrolled diabet Patient has no allergy to ondansetron or local anesthtic drug no forbid for spinal anesthesia Patient dosent use drugs which effect on HT35 receptor
Intervention groups
Patients will be randomly divided into three groups consist of receiving 6 mg of ondansetron, 8 mg of ondansetron, and distilled water. They are injected intravenously and then the patients are subjected to spinal anesthesia. Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and arterial blood oxygen saturation are measured and recorded every 15 minutes during surgery and every 15 minutes during the recovery period by an observer who is not by the research team. Any complication is recorded if it occurs during appropriate treatment
Main outcome variables
Systolic blood pressure, diastolic blood pressure, heart rate, mean arterial pressure, arterial oxygen saturation, nausea, vomiting, duration of surgery,duration of stay in recovery,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191109045371N1
Registration date: 2020-10-14, 1399/07/23
Registration timing: retrospective

Last update: 2020-10-14, 1399/07/23
Update count: 0
Registration date
2020-10-14, 1399/07/23
Registrant information
Name
Farhad Hasanvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 6966
Email address
farhadhasanvand94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
2020-03-20, 1399/01/01
Actual recruitment end date
2020-07-21, 1399/04/31
Trial completion date
2020-08-22, 1399/06/01
Scientific title
comparing the effect of two different doses of ondansetron on heart rate , blood pressure and blood oxygen saturation variation in caesarian surgery under spinal anesthesia
Public title
comparing the effect of two different doses of ondansetron on heart rate , blood pressure and blood oxygen saturation variation in caesarian surgery under spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 45 years old ASA number 1 and 2 Patient is cesarian candida that term pregnancy Patient has no disease like hypertention Patient has no uncontrolled diabet Patient has no allergy to ondansetron or local anesthtic drug no forbid for spinal anesthesia Patient dosent use drugs which effect on HT35 receptor
Exclusion criteria:
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study ,patients were divided on a basis of Random block making, into blocks consisting of six peoples.in each block, two patients received 8 milligrams of ondansetron, two patients received 6 milligrams of ondansetron, and two patients received normal saline. then by use of Random digits table, 15 different blocks of the so called blocks were randomly chosen. Drugs were drawn in three syringes of the same size and color by an out-of-study anesthesiologist and for every patient proportionate to his group, were given to the main anesthesiologist. Patient, main anesthesiologist, the person in charge of collecting and recording datas were unaware of the Type of the drug that was used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs were drawn in three syringes of the same size and color by an out-of-study anesthesiologist and for every patient proportionate to his group, were given to the main anesthesiologist. Patient, main anesthesiologist, the person in charge of collecting and recording datas were unaware of the Type of the drug that was used.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No 48,bijan alley , hakim nezami Ave
City
Isfahan
Province
Isfehan
Postal code
8175976665
Approval date
2019-06-02, 1398/03/12
Ethics committee reference number
IR.MUI.MED.REC.1398.446

Health conditions studied

1

Description of health condition studied
cesarean section
ICD-10 code
O75.82
ICD-10 code description
Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section

Primary outcomes

1

Description
Blood pressure
Timepoint
Befor operation and every 15 minute during operation and recovery
Method of measurement
mercury barometer

2

Description
blood oxygen saturation
Timepoint
Befor operation and every 15 minute during operation and recovery
Method of measurement
puls oxymeter

3

Description
heart rate
Timepoint
Befor operation and every 15 minute during operation and recovery
Method of measurement
puls oxymeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: patients take 6 mg ondansetron
Category
Treatment - Drugs

2

Description
Intervention group: patients take 8 mg ondansetron
Category
Treatment - Drugs

3

Description
Control group: patients take 4cc distilled water
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Farhad Hasanvand
Street address
Felezi bridge, Motahari ave
City
Isfahan
Province
Isfehan
Postal code
8177781771
Phone
+98 31 3236 7001
Email
BEHESHTI@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaghayegh haghju
Street address
Hezar zhrib ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Reza Shetabi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar jerib ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
0098 31 3660048
Fax
Email
hamidshetabi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Reza Shetabi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar jerib ave
City
Isfahan
Province
Isfehan
Postal code
8117473461
Phone
+98 31 3668 0048
Email
hamidshetabi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Hasanvand
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Hakim Nezami ave , Bijan alley
City
Isfahan
Province
Isfehan
Postal code
8175976665
Phone
+98 913 060 1487
Email
farhadhasanvand94@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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