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comparison effect of Ondansetron and Halopridol and Dexmedetomidine for ‎‎ prophylaxis of postoperative nausea and vomiting in patients undergoing ‎total abdominal hysterectomy ‎

Protocol summary

Study aim
comparison effect of Ondansetronand Halopridol and Dexmedetomidine for ‎‎ prophylaxis of postoperative nausea and vomiting in patients undergoing ‎total abdominal hysterectomy ‎
Design
This study is clinical trial and double blind. 114 patients candidate abdominal hysterectomy referring to Taleghani Hospital of Arak admitted. We divide patients randomly to three groups (Ondonestrone, haloperidol, and Dexmedetomidine) by simple randomization method.
Settings and conduct
This study is clinical trial and double blind. 114 patients undergoing abdominal hysterectomy referring to Taleghani Hospital of Arak admitted . Patients assigned randomly to three groups by simple randomization method.The patient is not aware of the treatment received.Participant and Analyzer are blind (double blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients are candidates for abdominal hysterectomy, ASA class I and II, no history of psychiatric and psychology, the absence of Parkinson's disease, motion sickness or chemotherapy history, patients under general anesthesia, patients aged 35-60 years, maximum surgical duration 150 minutes Exclusion criteria: surgical duration more than 150 minutes
Intervention groups
In the Haloperidol group, 2 milligrams of Haloperidol are given intravenously (equivalent to one milliliter) , In the Ondansetron group, 4 milligrams of Ondonestrone are given intravenously (equivalent to 1 milliliter) and In the Dexmeditomidine group, 1 micro gram in kilogram of Dexomedetomidine is given intravenously (equivalent to 1 milliliter).
Main outcome variables
vomiting score, nausea, sedation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N84
Registration date: 2018-08-29, 1397/06/07
Registration timing: registered_while_recruiting

Last update: 2018-08-29, 1397/06/07
Update count: 0
Registration date
2018-08-29, 1397/06/07
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
Recruitment complete
Funding source
Expected recruitment start date
2017-10-08, 1396/07/16
Expected recruitment end date
2018-10-08, 1397/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison effect of Ondansetron and Halopridol and Dexmedetomidine for ‎‎ prophylaxis of postoperative nausea and vomiting in patients undergoing ‎total abdominal hysterectomy ‎
Public title
comparison effect of Ondansetron and Halopridol and Dexmedetomidine for ‎‎ prophylaxis of postoperative nausea and vomiting in patients undergoing ‎total abdominal hysterectomy ‎
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients are candidates for abdominal hysterectomy ASA class I and II No history of psychiatric and psychology The absence of Parkinson's disease, motion sickness or chemotherapy history Patients under general anesthesia Patients aged 35-60 years Maximum surgical duration 150 minutes
Exclusion criteria:
Surgical duration time more than150 minutes
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not aware of the treatment received.Participant and Analyzer are blind (double blind).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Approval date
2017-10-08, 1396/07/16
Ethics committee reference number
IR.ARAKMU.REC.1396.111

Health conditions studied

1

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

Primary outcomes

1

Description
Vomiting score
Timepoint
4 and12 and 24 hours after surgery
Method of measurement
Vomitting score

2

Description
Nausea
Timepoint
After surgery
Method of measurement
Clinical observation

3

Description
Sedation
Timepoint
In recovery
Method of measurement
Ramsy score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the Haloperidol group, 2 milligrams of Haloperidol are given intravenously (equivalent to one milliliter).
Category
Treatment - Drugs

2

Description
Intervention group: In the Ondansetron group, 4 milligrams of Ondonestrone are given intravenously (equivalent to 1 milliliter).
Category
Treatment - Drugs

3

Description
Intervention group: In the Dexmeditomidine group, 1 micro gram in kilogram of Dexomedetomidine is given intravenously (equivalent to 1 milliliter).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Maryam Shokrpour
Street address
Taleghani hospital, Emam Khomeini street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
Mshokrpour@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@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 Maryam Shokrpour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani hospital, Emam khomeini street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
shokrpour@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Assistant 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
alikamaliir@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Lida Ahmadi
Position
student of medicin
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@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
When we publish article in journal.
When the data will become available and for how long
After the article is published
To whom data/document is available
researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
dr Alireza Kamali
What processes are involved for a request to access data/document
They have to write letters to the professors and the university
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