Protocol summary

Study aim
The aim of this study is to investigate the effect of preventive administration of two drugs (ondansetron and dexamethasone) on reducing hypotension and bradycardia in elderly patients undergoing spinal anesthesia.
Design
double blind randomized controlled trial on 120 patients who were Candidate for elective urology surgeries
Settings and conduct
120 patients ,attending Shahid Beheshti and Modarres Hospitals are divided into three groups . Group A: 4 mg Ondansetron, 5 minutes before S.A is injected . Group B: 5 minutes before spinal anesthesia, 8 mg of intravenous Dexamethasone is injected Group C: Medicine is not injected before S.A.. Blood pressure and heart rate monitoring is recorded in all 3 groups before & 30 minutes following the S.A
Participants/Inclusion and exclusion criteria
Inclusion ≤65 of age American Society of Anesthesiologists (ASA) physical status I, II EF>40% Patients who do not have a contraindication for spinal anesthesia (such as coagulation disorder, thrombocytopenia). Not allergic to local anesthetic No allergy to ondansetron or dexamethasone Not taking drugs related to steroids or serotonin (for example, selective serotonin reuptake inhibitors) Not suffering from uncontrolled cardiovascular, kidney, liver and thyroid diseases Exclusion Study confounding items such as: Occurrence of surgical complications such as bleeding, hemodynamic instability
Intervention groups
The patients are selected and randomly divided into 3 groups of 40 patients: First intervention group، Group A: 5 minutes before spinal anesthesia, 4 mg Ondansetron is injected intravenously Second intervention group Group B: 5 minutes before S A, 8 mg Dexamphetamine is injected & the control group Group C: No medicine is injected before S.A.
Main outcome variables
Systolic and Diastolic blood pressure, Heart rate, Ondansetron, Dexamethasone, Atropine, Ephedrine

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230513058164N1
Registration date: 2023-05-18, 1402/02/28
Registration timing: retrospective

Last update: 2023-05-18, 1402/02/28
Update count: 0
Registration date
2023-05-18, 1402/02/28
Registrant information
Name
Masoumeh Tork
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4424 7962
Email address
aban253@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-11, 1401/08/20
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
2022-11-11, 1401/08/20
Actual recruitment end date
2023-02-19, 1401/11/30
Trial completion date
2023-02-19, 1401/11/30
Scientific title
The comparative study of intravenous Ondansetron and Dexamethasone Effects on Reducing the Incidence of PostSpinal Anesthesia Hypotension in Elderly Patients Undergoing Urologic Surgeries
Public title
The comparative study of intravenous Ondansetron and Dexamethasone effects on reducing the incidence of postspinal anesthesia hypotension in elderly patients undergoing urologic surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
65 years of age or more American Society of Anesthesiologists (ASA) physical status EF>40% Patients who do not have a contraindication for spinal anesthesia (such as coagulation disorder, thrombocytopenia ) Not allergic to local anesthetic No allergy to ondansetron or dexamethasone Not taking drugs related to steroids or serotonin (for example, selective serotonin reuptake inhibitors) Not suffering from uncontrolled cardiovascular, kidney, liver and thyroid diseases
Exclusion criteria:
Study Confounding Items Such as: Occurrence of Surgical Complications Such as Bleeding Hemodynamic Instability
Age
From 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 120
Actual sample size reached: 120
Randomization (investigator's opinion)
Randomized
Randomization description
120 patients. are randomly assigned based on the inclusion and exclusion crietria, using the software of the website http://www.Randomization.com . Their information are registered and informed consent obtained. Based on the central randomization system , the patient is assigned to the study groups by contacting the randomization center . This is done by a hospital colleague not involved in other stages of the study .
Blinding (investigator's opinion)
Double blinded
Blinding description
.Patients are classified into three groups according to the randomization program and entered into the study according to the determined codes. In order to complete the study, the anesthesiologist assistant who is not participating in the study gives i.v. injections of Ondansetron or Dexamethasone in a 5 cc syringe preparation, 5 minutes prior to the spinal anesthesia. The patient, the caregivers of the operating room, the evaluator and the data analyst. are unaware of the type , dosage of drug injected.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yasuj University of Medical Sciences
Street address
Shahid Motahhari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2022-10-26, 1401/08/04
Ethics committee reference number
IR.YUMS.REC.1401.114

Health conditions studied

1

Description of health condition studied
Post spinal hypotension in elderly patients
ICD-10 code
I95
ICD-10 code description
Hypotension

2

Description of health condition studied
Post Spinal Bradycardia
ICD-10 code
R00.1
ICD-10 code description
Bradycardia, unspecified

Primary outcomes

1

Description
Systolic Blood Pressure
Timepoint
5 minutes before and 30 minutes following Spinal Anesthesia .
Method of measurement
Sphygmomanometer

2

Description
Diastolic Blood Pressure
Timepoint
5 minutes before and 30 minutes following Spinal Anesthesia
Method of measurement
Sphygmomanometer

3

Description
Heart Rate
Timepoint
5 minutes before and 30 minutes following Spinal Anesthesia Procedure
Method of measurement
Pulse Oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group A : Ondansetron Amp 4mg ,slow iv , Single Dose، 5 minutes prior to Spinal Anesthesia.
Category
Prevention

2

Description
Intervention Group B: Dexamethasone Amp 8mg iv , Single Dose , 5 minutes prior to Spinal Anesthesia,.
Category
Prevention

3

Description
The control group consists of 40 patients who are randomly selected and receive a study participation code. They receive no injectable drug before spinal anesthesia.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Yasuj Shahid Beheshti Hospital
Full name of responsible person
Dr Mehrdad Bagheri
Street address
Shahid Montazeri
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
759174857
Phone
+98 74 3322 1813
Email
pr@yu.ac.ir

2

Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Dr Saeed Alipour
Street address
Saadatabad
City
Tehran
Province
Tehran
Postal code
3438319987
Phone
+98 21 2207 4087
Email
modarres@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr MohammadAmin Gholamnezhad
Street address
Shahid Motahhari
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3333 7220
Email
info@myreshte.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Masoumeh Tork
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Marzdaran
City
Tehran
Province
Tehran
Postal code
1463755184
Phone
+98 21 4424 7963
Email
aban253@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Masoumeh Tork
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Marzdaran
City
Tehran
Province
Tehran
Postal code
1463755184
Phone
+98 21 4424 7962
Email
aban253@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Masoumeh Tork
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
N.25, Malek, Isar, Marzdaran
City
Tehran
Province
Tehran
Postal code
1463755184
Phone
+98 21 4424 7962
Fax
Email
aban253@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data recording sheets، Result Charts , Analytical Charts available in article link and research text
When the data will become available and for how long
Available while article is accessible
To whom data/document is available
Research team
Under which criteria data/document could be used
Upon formal request
From where data/document is obtainable
Researcher
What processes are involved for a request to access data/document
Formal written request
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