1. Home
  2. Approved trials
  3. » فارسی

Effect of Ginger (Zingiber officinal) on the prevention of postoperative nausea and vomiting after breast surgeries

Protocol summary

Study aim
Evaluation the effect of Ginger (Zingiber officinal) on the prevention of postoperative nausea and vomiting after breast surgeries
Design
80 patients will be selected as a research sample ,statistical calculations,that are eligible for inclusion in the study after the surgery completion and patient exit from anesthesia,then they will be divided in to intervention and control groups with binary blocking. in the intervention group ,4 ginger tablets (containing ginger powder)and in control group pills,similar to ginger capsules in terms of color ,odor,taste and shape ,containing ineffective pea powder will be used.the study is a randomized with parallel groups and double-blinded with control group.
Settings and conduct
The study will be conducted in surgery room of Imam Reza hospital .in intervention group 4 ginger tablets and in control group 4 placebo exactly similar to ginger tablets,will be prescribed one hour before surgery. immediately after completion of surgery and in recovery ,at 1,2,4,6,12,24 hours after operation ,patients will be asked about their nausea and vomiting .in this study patients and anesthesiologist will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion:All of Patients who Being a Candidate for Elective Surgery and Based on ASA Classification are 1 or 2 ASA Class. Exclusion:Patients with Cardiovascular, Hepatic and Kidney Disease; Patients under Prescription of anti-nausea Drugs in the last 24 hours; Pregnancy and lactation.
Intervention groups
Patients in the intervention group will be given four ginger capsules containing ginger powder and patients in the control group will be received two capsules weighting 250 mg,containing chickpea powder that would be similar in shape,color,taste and odor to the capsules in group one,both along with 30ml water one hour before surgery.
Main outcome variables
Severity of postoperative nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150125020795N10
Registration date: 2019-12-22, 1398/10/01
Registration timing: registered_while_recruiting

Last update: 2019-12-22, 1398/10/01
Update count: 0
Registration date
2019-12-22, 1398/10/01
Registrant information
Name
Samad Golzari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3556 6183
Email address
golzaris@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ginger (Zingiber officinal) on the prevention of postoperative nausea and vomiting after breast surgeries
Public title
Effect of Ginger (Zingiber officinal) on the prevention of postoperative nausea and vomiting after breast surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of Patients who Being a Candidate for Elective Surgery and Based on ASA Classification are 1 or 2 ASA Class
Exclusion criteria:
Patients with Cardiovascular, Hepatic and Kidney Disease. Patients under Prescription of anti-nausea Drugs in the last 24 hours. Pregnancy and lactation
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study we use balanced randomization that at first four blocks with 9 combination will be formed and blocks will be numbered from 1to9. Compared to the simple randomization method, in this method the size of equilibrium of intervention and placebo groups will be established both during and at the end of study(randomization method is pre and post accidental blocks and will be done by randlist software)
Blinding (investigator's opinion)
Double blinded
Blinding description
All of Patients do not Know about used Drugs in this Study and Anesthesiologist who evaluated clinical response to administerated drugs
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
2019-07-15, 1398/04/24
Ethics committee reference number
IR.TBZMED.REC.1398.433

Health conditions studied

1

Description of health condition studied
Prevention of nausea and vomiting after surgery
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
Recovery and at 1,2,4,6,12 and 24 h postoperatively
Method of measurement
scoring by (0=non, 1=nausea, 2=vomiting, 3=vomiting >2 times)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Patients in the first group will be given four ginger capsules containing ginger powder with 30 ml water befor surgery .
Category
Treatment - Drugs

2

Description
Control group:patients in the second group will be received two capsules weighting 250 mg,containing pea powder that would be similar in shape,color,taste and odor to the capsules in the intervention group along with 30 ml of water one hour before surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Samad Eslaam Jamal Golzari
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
golzaris@tbzmed.ac.ir

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
Samad Eslam Jamal Golzari
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
golzaris@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
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
golzaris@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
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
golzaris@tbzmed.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
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 .Samad Eslam Jamal Golzari, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran Phone+98 413 3341994 Fax+98 41 33341994 golzaris@tbzmed.ac.ir
What processes are involved for a request to access data/document
Correspondence through email only.
Comments
Loading...