Prevention of nausea and vomiting in middle ear surgery
Design
Clinical trial with intervention and control groups, with parallel groups, double-blind, randomized, sample of 100 patients. Randlist software was used for randomization.
Settings and conduct
The study will be performed in the recovery department of Imam Reza Hospital in Tabriz. the variables of nausea, vomiting will be completely examined and recorded by the anesthesiologist in both groups.The severity of postoperative nausea and vomiting in recovery at 4, 8, 12, 16,20 and 24 hours and based on scoring (0 = no nausea and vomiting, 1 = nausea, 2 = vomiting and 3 = vomiting more than 2 times) Will be reviewed .In this study, patients and anesthesiologists are blinded to the study,but the theses owner student is fully aware of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All people aged 18 to 60 are candidates for middle ear surgery
Has ASA grade,class I&II
Exclusion criteria:History of nausea and vomiting after surgery
History of migraine headache
History of digestive problems
Pregnant and in menstruating period
History of motion sickness
Take anti-nausea medication 48 hours before surgery
Intervention groups
Intervention group:In this group, they will receive 4 mg of intravenous ondansetron before induction of anesthesia.
Control group:In this group, 50 mg of diphenhydramine will be injected intravenously before induction of anesthesia.
Main outcome variables
Severity of nausea and vomiting.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150217021121N5
Registration date:2020-08-05, 1399/05/15
Registration timing:registered_while_recruiting
Last update:2020-08-05, 1399/05/15
Update count:0
Registration date
2020-08-05, 1399/05/15
Registrant information
Name
Reza Movassaghi Gargari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 8740
Email address
movassaghir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effect of intravenous diphenhydramine and ondansetron on post middle ear surgery nausea and vomiting
Public title
the effect of intravenous diphenhydramine and ondansetron on nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All people aged 18 to 60 are candidates for middle ear surgery
Has ASA grade,class I&II
Exclusion criteria:
History of nausea and vomiting after surgery
History of migraine headache
History of digestive problems
Pregnant and in menstruating period
History of motion sickness
Take anti-nausea medication 48 hours before surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
We will construct 6 blocks in AABB, BBAA, ABAB, BABA, ABBA and BAAB using four blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 25 units of 4 blocks will be selected so that we consider having 50 people in control group (A) and 50 people in intervention group (B). Therefore, we will do block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, the thesis owner student provides the drugs to the anesthesiologist and is the only person who is not blind to the study.The anesthesiologist, who is in charge of the patient's anesthesia management, injects the drug through coded syringes that have already been prepared by the thesis owner.So that anesthesiologist is unaware of the injected drug to patient during injection.The anesthesia nurse, who is responsible for collecting information and variables from the patient and is unaware of the type of prescribed drug, fills in the checklist during surgery and recovery.The patient is also unaware of the type of Injecting drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5183915881
Approval date
2020-07-13, 1399/04/23
Ethics committee reference number
IR.TBZMED.REC.1399.389
Health conditions studied
1
Description of health condition studied
Postoperative nausea and vomiting
ICD-10 code
Y84
ICD-10 code description
Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Severity of postoperative nausea and vomiting
Timepoint
In the post-anesthesia care department every 24 hours for 24 hours after surgery
Method of measurement
Based on scoring (0 = no nausea and vomiting, 1 = nausea, 2 = vomiting and 3 = vomiting more than 2 times
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In this group, they will receive 4mg of intravenous ondansetron before induction of anesthesia.
Category
Treatment - Drugs
2
Description
Control group:In this group, 50 mg of diphenhydramine will be injected intravenously before induction of anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Reza Movvassaghi
Street address
Department of Anesthesiology, Faculty of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
rz_movassaghi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical sciences research vice chancellor
Full name of responsible person
Dr Abolghasem Joyban
Street address
Vice chancellor for research, ِDaneshgah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz university of medical sciences research vice chancellor
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
Tabriz University of Medical Sciences
Full name of responsible person
Reza Movvassaghi
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
rz_movassaghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Movvassaghi
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
rz_movassaghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Movvassaghi
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
rz_movassaghi@yahoo.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
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after making peoples unrecognizable.
When the data will become available and for how long
Starting 6 months after publication .
To whom data/document is available
Documents will be available for people working in academic institutions and also people working in businesses.
Under which criteria data/document could be used
There will be no specific limitations to the utilization of the data
From where data/document is obtainable
Dr .Reza Movassaghi, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran Phone+98 413 3341994 Fax+98 41 33341994 rz_movassaghi@yahoo.com
What processes are involved for a request to access data/document
Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week.