Protocol summary

Summary
abstract Postoperative nausea and vomiting is an unpleasant complication caused by various routes. In recent years, several studies have been conducted to evaluate the pharmacological methods including special anesthetics and anti-vomiting drugs in reducing postoperative nausea and vomiting, each of which has There are many complications that lead us to the use of herbal medicines, but the share of non-pharmacological methods such as: Oral consumption of herbs or herbs is low. Non-pharmacological studies, most of which began treatment after nausea and vomiting, and in a few others that were used preventively, Researcher decided to use the effect of peppermint tablets on the prevention of nausea and vomiting after inguinal hernia surgery. Entry criteria: aged 18 to 65 years; general anesthesia with intubation; no PEPPERMINT allergy. Exit criteria: Failure to comply with the desired anesthetic protocol; Duration of at least 30 minutes and up to 120 minutes; Don’t use Dexamethasone, hydroquitizon or anti-nausea medicine before or during anesthesia. Population studied; patients with inguinal hernia hospitalized in the emergency department of Sabzevar Hospital. Sample size: 90 patients with inguinal hernia were exposed to peppermint and placebo tablets for six hours. The sampling period was 9 months. Initial outcomes include complete satisfaction of patients participating in the plan and no specific adverse events reported or observed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017081332205N1
Registration date: 2017-08-13, 1396/05/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-13, 1396/05/22
Registrant information
Name
Mohamad Borabadi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 2159
Email address
borabadi77@gmail.com
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences Research Committee
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-04-30, 1396/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peppermint tablet on prevention of postoperative nausea and vomiting in inguinal hernia
Public title
The effect of peppermint tablet on prevention of postoperative nausea and vomiting in inguinal hernia
Purpose
Prevention
Inclusion/Exclusion criteria
Entry Criteria: 1- Having a minimum age of 18 years and a maximum of 65 years of age; 2- Perform general anesthesia with intubation; 3- Underlying surgical procedure for inguinal hernia; 4- Non-allergenic to peppermint; 5-Gastrointestinal criteria: no wounds or inflammation, no history of gastric reflux, no biliary dysfunction, no bowel obstruction, no digestive tract ulceration, history of nausea and vomiting after the previous operation, no addiction to alcohol; 6- Cardiovascular system: Having ASA class (I, II) ; 7-Nervous system: Not having Alzheimer's disease and Parkinson's disease, not having internal ear disorders and migraines, history of travel sickness (seeing or riding) or vertigo; 8- Respiratory system: Absence of respiratory disease; 9- Fertility and lactation: Not pregnancy, lactation, absence of menstruation; 10- Endocrine: Absence of diabetes; Exit criteria: 1- Failure to protocol of anesthesia; 2.- Length Duration of anesthesia less than 30 minutes and more than 120 minutes ; 3- Receiving dexamethasone, hydrocortiizon or anti-nausea drug before or during anesthesia.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sabzevar University Medical Sciences Ethics Committee
Street address
Center House Asadabadi Street
City
Sabzevar
Postal code
Approval date
2016-07-12, 1395/04/22
Ethics committee reference number
IR.MEDSAB.REC.1395.52

Health conditions studied

1

Description of health condition studied
Patient Under Anesthesia
ICD-10 code
K40.9
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene

Primary outcomes

1

Description
Nausea & Vometing
Timepoint
Preoperation & Postoperation for 6 Hour
Method of measurement
Visual Scale Nausea & Vometing

Secondary outcomes

empty

Intervention groups

1

Description
In the control group, one placeboisotrophy isoseda company 30 minutes to 45 minutes before surgery and one other tablet of the same 3 hours after surgery, if complete consciousness and airways reflexes are used sucking.
Category
Prevention

2

Description
In the intervention group, one tablet from Isooda company 30 minutes to 45 minutes before the surgery, and one other tablet of the same 3 hours after the surgery, if complete consciousness and airway reflexes are used sucking.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Emdad Hospital shahid beheshti
Full name of responsible person
Borabadi Mohamad
Street address
Razi Street - Shahid DR.Mohamad Beheshti Emdas hospital
City
Sabzevar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar Medical Univercity Research Committee
Full name of responsible person
DR. Alireza Moslem
Street address
Asadabadi Street Center House
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar Medical Univercity Research Committee
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Borabadi Mohamad
Position
Nursing Specialist Intensive Care Unit Student Degree
Other areas of specialty/work
Street address
Asadabadi street - Center house
City
Sabzevar
Postal code
Phone
+98 51 4401 1000
Fax
Email
borabadi77@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
DR.Yosefi mogadam manige
Position
Heart anesthesiologist
Other areas of specialty/work
Street address
Center house medsab
City
Sabzevar
Postal code
Phone
+98 51 4401 1000
Fax
Email
ymanijeh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Borabadi Mohamad
Position
Nursing Specialist Intensive Care Unit Student Degree
Other areas of specialty/work
Street address
Emdad Hospital
City
Sabzevar
Postal code
Phone
+98 51 4464 0115
Fax
Email
borabadi77@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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