Aim of this study is comparison Haloperidol and dexmedetomidine and plasil and ginger for nausea and vomiting after laparoscopy.
Design
88 patients with laparascopy surgery will referred valiasr hospital will inter in this study. We will divide the patients to 4 groups.
Settings and conduct
This study is clinical trial and double blind.88 patients with laparascopy surgery will referred valiasr hospital will inter this study.This study is double blind. Outcome elevator and analyzer are blind (double blind). Outcome elevator and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Laparoscopic candidate; no history of psychiatric and psychoeducational disorders; no history of Parkinson's disease, motion sickness or no history of chemotherapy; general anesthetic candidate; surgical duration 90 to 150 minutes
Exclusion criteria: Lack of Conscientiousness
Intervention groups
We inject 25 micro gram Dexmedetomidin slowly before cutting surgery in Dexmedetomidine group. We inject 10 milligram Metoclopramide 30 minute before final surgery in Metoclopramide group. We inject 0/5 milligram of ampule Haloperidol in Haloperidol group. We treat ginger 1 hours before anesthesia 1 gram ginger orally in ginger group.
Main outcome variables
vomiting-nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N88
Registration date:2018-11-25, 1397/09/04
Registration timing:registered_while_recruiting
Last update:2018-11-25, 1397/09/04
Update count:0
Registration date
2018-11-25, 1397/09/04
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
2018-06-22, 1397/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Haloperidol and dexmedetomidine and plasil and ginger for nausea and vomiting after laparoscopy
Public title
Comparison Haloperidol and dexmedetomidine and plasil and ginger for nausea and vomiting after laparoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Laparoscopic candidate
No history of psychiatric and psychoeducational disorders
No history of Parkinson's disease,motion sickness or no history of chemotherapy
General anesthetic candidate
surgical duration 90 to 150 minutes
Exclusion criteria:
Lack of conscientiousness
Age
From 18 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:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Outcome elevator and analyzer are blind (double blind). Outcome elevator and analyzer don't aware from grouping.
Placebo
Not 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
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2018-05-30, 1397/03/09
Ethics committee reference number
IR.ARAKMU.REC.1397.65
Health conditions studied
1
Description of health condition studied
Laparascopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nausea
Timepoint
Recovery and 2 and 4 hours after surgery
Method of measurement
Observation
2
Description
Vomiting
Timepoint
Recovery and 2 and 4 hours after surgery
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We inject 25 micro gram Dexmedetomidin slowly before cutting surgery.
Category
Treatment - Drugs
2
Description
Intervention group: We inject 10 milligram Metoclopramide 30 minute before final surgery.
Category
Treatment - Drugs
3
Description
Intervention group: We inject 0/5 milligram of ampule Haloperidol
Category
Treatment - Drugs
4
Description
Intervention group: We treat ginger 1 hours before anesthesia 1 gram ginger orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Abolfazl Mohtarami
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
a.mohtarami@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University Of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmanzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3471 3645
Fax
+98 86 3471 3645
Email
m.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
Vice chancellor for research, 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 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
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Abolfazl Mohtarami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
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
a.mohtarami@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Vahid Kashani tabar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
kashani@gmail.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 Abolfazl Mohtarami
What processes are involved for a request to access data/document
They have to write letters to the professors and the university