Protocol summary

Study aim
Comparison of the effects of ginger and dexamethasone and ondansetron and promethazine in reducing postoperative nausea and vomiting in patients undergoing hysterectomy
Design
The study will be double blind and clinical trial.100 patients will be randomly divide into 4 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients who are candidates for hysterectomy at Sina Rezaei Ashtiani Hospital in Arak are divided into 4 groups using simple randomization with the envelope method. The study is double-blind, and blinding of the analyzer, outcome evaluator, and participant is performed.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: no history of cancer, no history of high blood pressure, 40 to 60 years, platelet count above 100000, no history of intestinal obstruction and hepatitis, no use of anti-nausea and anti-vomiting drugs or drugs that induce them, no long-term treatment with corticosteroid drugs, no history of allergy to ginger Exclusion Criteria: lack of patient's consent to participate in the study, willingness to cooperate, patients who experience cardiopulmonary arrest during surgery
Intervention groups
Intervention Groups: Ginger Group:patients in the ginger group receive two 500 miligeram Vomegan Dineh ginger tablets, each containing 500 mg of ginger, one hour before the surgery. To standardize the appearance of the received medications, they also receive 4 millileter of distilled water in a serum. Ondansetron Group: patients in the ondansetron group receive 8 miligeram of ondansetron. Dexamethasone Group: patients receive 8 miligeram of dexamethasone intravenously before anesthesia induction. Promethazine Group:Patients receive 6.25 miligeram of promethazine intravenously before anesthesia induction.
Main outcome variables
Nausea, vomiting, sedation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N201
Registration date: 2025-11-17, 1404/08/26
Registration timing: prospective

Last update: 2025-11-17, 1404/08/26
Update count: 0
Registration date
2025-11-17, 1404/08/26
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-11-22, 1404/09/01
Expected recruitment end date
2026-11-22, 1405/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of ginger and dexamethasone and ondansetron and promethazine in reducing postoperative nausea and vomiting in patients undergoing hysterectomy
Public title
Comparison of the effects of ginger and dexamethasone and ondansetron and promethazine in reducing postoperative nausea and vomiting in patients undergoing hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No history of cancer No history of high blood pressure Age between 40 to 60 years Ability to swallow the pill used in the study Platelet count above 100000, no history of intestinal obstruction and hepatitis No use of anti-nausea and anti-vomiting drugs or drugs that induce them No history of allergy to ginger No use of blood-thinning and anticoagulant drugs before surgery
Exclusion criteria:
Lack of patient's consent to participate in the study Willingness to cooperate Patients who experience cardiopulmonary arrest during surgery Patients who are referred to the intensive care unit for any reason
Age
From 40 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into4 groups using a permuted balanced block randomization method with the size of blocks8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. The analysis is done by the analyst and outcome evaluator (double-blind) and the participant. The analyst, evaluator, and participant are unaware of the consequences of grouping. The patients under study, as well as all project staff, including surgeons, anesthesia technicians, scrub nurses, and interns, will be unaware of how patients are assigned to the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2025-10-19, 1404/07/27
Ethics committee reference number
IR.ARAKMU.REC.1404.273

Health conditions studied

1

Description of health condition studied
Hysterectomy
ICD-10 code
N99.3
ICD-10 code description
Prolapse of vaginal vault after hysterectomy

Primary outcomes

1

Description
Incidence of nausea
Timepoint
Recovery and 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Observation

2

Description
Vomiting
Timepoint
Recovery and 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Score 0 to 4

3

Description
Sedation
Timepoint
In recovery and 1, 2 and 4 hours after surgery
Method of measurement
Ramsay score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Patients in the ginger group receive two 500 mg Vomegan Dineh ginger tablets (manufactured by Dineh Bern Company), each containing 500 mg of ginger, one hour before the surgery. To standardize the appearance of the received medications, they also receive 4 ml of distilled water in a serum.
Category
Treatment - Drugs

2

Description
Intervention group2: Patients in the ondansetron group receive 8 mg of ondansetron (manufactured by Alborz Darou Pharmaceutical Company).
Category
Treatment - Drugs

3

Description
Intervention group3: Patients receive 8 mg of dexamethasone (manufactured by Alborz Darou Pharmaceutical Company) intravenously before anesthesia induction.Promethazine Group:
Category
Treatment - Drugs

4

Description
Intervention group4: Patients receive 6.25 mg of promethazine (manufactured by Alborz Darou Pharmaceutical Company) intravenously before anesthesia induction.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr Alireza Kamali
Street address
Sardasht, Sina rezaee ashtiani hospital
City
Arak
Province
Markazi
Postal code
3836544999
Phone
+98 86 3417 3505
Email
alikamaliir@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Behzad Khansarinejad
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
khansarinejad@arakmu.ac.ir
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
Dr Hesamedin Modir
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
modir.he@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 68 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Karimi
Position
resident of anesthesilogy
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Medicine department, Payambar Azam complex, Basij square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
karimi@gmail.com
Web page address

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
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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