Reducing the effects of recovery (nausea, vomiting and pain) after tempanoplasty surgery with the help of diphenhydramine
Design
A total of 100 patients will be selected as a research sample ,then divided into two groups of intervention and control. The intervention group will receive Diphenhydramine and the control group will receive normal salin as a placebo. The study is a randomized, double-blind, placebo-controlled clinical trial.
Settings and conduct
The study will be performed in the recovery department of Imam Reza Hospital in Tabriz. the variables of nausea, vomiting and pain will be completely examined and recorded by the anesthesiologist in both groups.The severity of postoperative nausea and vomiting in recovery at 3, 6, 12, 18 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 and the severity of the pain at the same time will be assessed by a four-digit verbal rating scale.In this study, patients and anesthesiologists are blinded to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Conscious patients over the age of 18 with ASA grade,class I&II
Lack of sensitivity to the study drug
exclusion criteria:
Having middle ear disease
History of nausea and vomiting over the past 24 hours
Pregnant and breastfeeding woman.
Intervention groups
Intervention group:In this group, 25 mg of diphenhydramine will be injected before the start of anesthesia.
Control group:In this group only 5 cc normal saline (as a placebo) will be injected completely with the specifications of the drugs of the intervention group before the start of anesthesia.
Main outcome variables
Severity of pain , Severity of nausea and vomiting.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150217021121N4
Registration date:2020-04-28, 1399/02/09
Registration timing:registered_while_recruiting
Last update:2020-04-28, 1399/02/09
Update count:0
Registration date
2020-04-28, 1399/02/09
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
2020-04-20, 1399/02/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pre-treatment with diphenhydramine on the complications of recovery in minor ear, nose and throat surgeries (tympanoplasty).
Public title
The effect of diphenhydramine on recovery complications in tempolanoplasty surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious patients over the age of 18 with ASA grade,class I&II
Lack of sensitivity to the study drug
Exclusion criteria:
Having middle ear disease
Patients with a history of pelvic surgery
History of nausea and vomiting over the past 24 hours
Pregnant and breastfeeding woman
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients wishing to participate in the study who meet the inclusion criteria will be selected through convenient sampling and then randomly assigned to two control and intervention groups using Randlist software
Blinding (investigator's opinion)
Double blinded
Blinding description
The anesthesiologist who is responsible for the patients management to induce anesthesia will administer the medicine(s) via coded syringes which have been prepared previously and therefore he/she will not be aware of the injected drug. Meanwhile the anesthesia nurse who is responsible for collection of patients' information and study variables and is unaware of the administered drug will fill the check- list during surgery and in the recovery room. Also the patient is unaware of the injected medicine.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Faculity of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-03-09, 1398/12/19
Ethics committee reference number
IR.TBZMED.REC.1398.1292
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
2
Description of health condition studied
Postoperative pain
ICD-10 code
T88.59
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Severity of postoperative nausea and vomiting
Timepoint
Recovery and at 3, 6, 12,18 and 24 hours postoperatively
Method of measurement
scoring by (0=non, 1=nausea, 2=vomiting, 3=vomiting >2 times)
2
Description
Severity of postoperative pain
Timepoint
Recovery and at 3, 6, 12,18 and 24 hours postoperatively
Method of measurement
Four Numerical Verbal Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In this group, 25 mg of diphenhydramine will be injected before the start of anesthesia.
Category
Treatment - Drugs
2
Description
Control group:In this group only 5 cc normal saline (as a placebo) will be injected completely with the specifications of the drugs of the intervention group before the start 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
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
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 collected deidentified IPD, IPD collected for the primary outcome measure are to be shared
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.