Protocol summary

Study aim
Comparison of the effects of three drugs: ginger, ondansetron, and droperidol on nausea and vomiting after hysterectomy.
Design
The clinical trial included three groups of ondansetron, droperidol, and ginger, and each group included 25 participants in parallel groups, double-blind, randomized, phase 2 on a total of 75 patients. All eligible patients will be randomly assigned to the three mentioned groups by the random block method.
Settings and conduct
patients in the ginger group, one hour before the operation, receive 4 ginger capsules, each containing 250 mg of ginger, and 4 ml of distilled water added to the serum to equalize the form of the received drugs. People in the ondansetron group receive 8 mg of ondansetron and 4 placebo capsules in the droperidol group, 2.5 mg of droperidol, and 4 placebo capsules. The preparation of the drugs is done by the researcher to blind the clinical caregiver of the patient. Then, in the period of 2, 4, and 6 hours after the operation, the patient's nausea will measure by the vas scale and the number of the patient's vomiting will record.
Participants/Inclusion and exclusion criteria
Entry criteria include no cancer, no high blood pressure, age between 18-60 years, ability to swallow the capsules used in the study, platelet count above 100,000, no intestinal obstruction and hepatitis, no use of anti-nausea and vomiting drugs or drugs that cause it, no long-term treatment with corticosteroid drugs, and no history of ginger allergy, not using blood thinners and anticoagulants before the operation, and the exclusion criterion is the patient's unwillingness to continue the study.
Intervention groups
Ondansetron group, ginger group, droperidol group
Main outcome variables
Vomiting and the number of times the patient vomits are asked and recorded.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230128057257N1
Registration date: 2023-02-05, 1401/11/16
Registration timing: registered_while_recruiting

Last update: 2023-02-05, 1401/11/16
Update count: 0
Registration date
2023-02-05, 1401/11/16
Registrant information
Name
Reza Latifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3412 0065
Email address
dr.r.latifi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-31, 1401/11/11
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of ginger, ondansetron and droperidol on nausea and vomiting after hysterectomy
Public title
Comparison of the effects of ginger, ondansetron and droperidol on nausea and vomiting after hysterectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for hysterectomy surgery Willingness to participate in the study after obtaining informed consent Age between 18-60 years The ability to swallow the capsules used in the study Platelet count above 100000
Exclusion criteria:
Having cancer Hypertension Intestinal obstruction and hepatitis Taking anti-nausea and vomiting drugs or drugs that cause it Long-term treatment with corticosteroid drugs Ginger allergy history Use of blood thinners and anticoagulants before surgery
Age
From 18 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
All patients with the entry criteria will be divided into three equal groups using a randomized block method; for each of the patients, the drugs studied in three groups were prepared by the anesthesiologist and they were prepared in the form of syringes of the same shape and color and with the same volume, and only 1-2-3 labels were placed on them. Then it will be given to the anesthetist technician of the project (who does not know the type of drugs) to be injected into the patients, also the patients do not know the type of drugs received. Additionally, the intern in charge of the project, who is responsible for completing the project questionnaires after the surgery, is also not aware of the type of study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study. Blinding of the participants was done using the same appearance of the drugs. Also, the patients did not have any information about which group they were assigned to. The blinding of the researcher was also done in such a way that one person delivered the medicine to a patient who did not know its type.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2022-12-11, 1401/09/20
Ethics committee reference number
IR.ARAKMU.REC.1401.276

Health conditions studied

1

Description of health condition studied
Postoperative nausea and vomiting
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The amount of nausea and vomiting after surgery
Timepoint
2, 4, and 6 hours after surgery
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: ondansetron, one hour before surgery, 8 mg of ondansetron by injection
Category
Prevention

2

Description
Intervention group: droperidol, one hour before surgery, 2.5 mg droperidol injection
Category
Prevention

3

Description
Intervention group: Ginger, one hour before the operation, 4 ginger capsules, each containing 250 mg of ginger.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani Educational and Therapeutic Center
Full name of responsible person
Maryam Shokrpour
Street address
Taleghani Educational Medical Center, West Imam Khomeini Street
City
Arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3277 6063
Email
maryam_shokrpour@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
mehdi salehi
Street address
Research and Technology Vice-Chancellor, University complex of the Prophet (PBUH), Basij Square (Sardasht)
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
salehi58@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Reza Latifi
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Jannat street, Shariati Blvd.
City
Arak
Province
Markazi
Postal code
3813695519
Phone
+98 86 3412 0065
Email
dr.r.latifi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Maryam Shokrpour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani Educational Medical Center, West Imam Khomeini Street
City
Arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3277 6063
Email
maryam_shokrpour@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Reza Latifi
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Jannat street, Shariati Blvd
City
Arak
Province
Markazi
Postal code
3813695519
Phone
+98 86 3412 0065
Email
dr.r.latifi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
In order to protect the privacy and personal information of the patient, the non-disclosure of personal information and other such information is mentioned in the informed consent form to obtain the consent of the patient and her family.
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
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