Determining the effect of midazolam,ondansetron and their combination on post strabismus surgery nausea-vomiting prevention
Design
This study will be conducted as a randomized double-blinded clinical trial in four groups.Randomization will be done by random allocation software .The number of patients in each group is 40 and the total sample size is 120.clinical trial will be conducted at phase 3.
Settings and conduct
This randomized double-blinded clinical trial will be conducted with 160 patients in Feyz hospital,Isfahan,Iran.In this study patients and researchers will be blinded.
Participants/Inclusion and exclusion criteria
1)ASA I-II
2)Age betwen 18-62 years
3)Candidate for strabismus surgery
4)The desire to participate in the study
Intervention groups
In this study patients are randomly divided into 4 groups:
group m receive midazolam
group o receive ondansetron
group mo receive midazolam and ondansetro
group s or control group receive normal saline
Main outcome variables
1) Nausea frequency
2) Nausea Intensity
3) Vomiting frequency
4) Vomiting intensity
5)Pain frequency
6) Pain intensity
7)Time of extubation
8) Recovery time
9)Patient satisfaction
10)Time of eating and drinking
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039326N8
Registration date:2019-08-08, 1398/05/17
Registration timing:prospective
Last update:2019-08-08, 1398/05/17
Update count:0
Registration date
2019-08-08, 1398/05/17
Registrant information
Name
Hamidreza Shetabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
hamidshetabi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of midazolam ,ondansetron and their combination on post strabismus surgery nausea-vomiting prevention
Public title
Effect of midazolam ,ondansetron and their combination on post strabismus surgery nausea-vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I-II
Candidate for strabismus surgery
Age between 18-62 years
The desire to participate in the study
Exclusion criteria:
Patient with motion sickness disease
Receiving an anti-emetic drug in the last 24 hours
Patient being treated with opioid
Pregnant women
smokers
Age
From 18 years old to 62 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by Random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blinded study.
patients and researchers are unaware of patients groups and type of medication.
The medications will be prepared by an anesthetist who is unaware of the
patients groups and will be covered by an aluminium foil and encoded by an anesthetist.Demographic information,post surgical nausea and vomiting,patient satisfaction and other variable will be collected by a person who is not aware of the drugs and patients.
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
Isfahan university of medical sciences, Hezarjarib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.MUI.MED.REC.1398.174
Health conditions studied
1
Description of health condition studied
Strabistmus
ICD-10 code
H50.9
ICD-10 code description
Unspecified strabismus
Primary outcomes
1
Description
Intensity and frequency of nausea and vomiting
Timepoint
0-2 and 2-24 hours after surgery
Method of measurement
Calculating nausea-vomiting frequency by questionnaire and nausea-vomiting intensity by Visual Analogue Scale
Secondary outcomes
1
Description
pain frequency
Timepoint
1)First 0-2 hours 2) first 2-24 hours
Method of measurement
questionnaire
2
Description
Pain intensity
Timepoint
1)first 0-2 hours 2)first 2-24 hours
Method of measurement
Visual analogue scale
3
Description
Time of extubation
Timepoint
After the end of the surgery
Method of measurement
A Period between end of the surgery and extubation measured By anesthesiologist
4
Description
Recovery time
Timepoint
After the end of the surgery
Method of measurement
A period between the end of the surgery and going to the ward that is measured by modified aldrete score
5
Description
Patient satisfaction
Timepoint
At the time of the patient discharge
Method of measurement
Likert scale
6
Description
Time of eating and drinking
Timepoint
After the end of the surgery
Method of measurement
The first time of eating and drinking After the surgery
Intervention groups
1
Description
Intervention group 1: The patients in the group one receive 0.75mg/kg intravenous midazolam after the beginning of the anesthesia .
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients in group 2 receive 4mg intravenous ondansetron after the beginning of the anesthesia.
Category
Treatment - Drugs
3
Description
Intervention group 3: Patients in group 3 receive combination of 0.75mg/kg midazolam and 4mg ondansetron intravenously after the beginning of the anesthesia.
Category
Treatment - Drugs
4
Description
Control group: Patient in this group receive 2cc normal saline intravenously after the beginning of the anesthesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Feyz Hospital , Modares St
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Hamidshetabi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaqayeq Haghjooye Javanmard
Street address
Vice chancellery of research and technology , Isfahan University of Medical Sciences, Hezarjarib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Sh_haghjoo@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
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۶۴
Phone
+98 31 3668 8138
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
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۶۴
Phone
+98 31 3445 2034
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
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۶۴
Phone
+98 31 3445 2034
Email
Hamidshetabi@med.mui.ac.ir
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