Protocol summary

Summary
Aim of this study comparison of effect of Dexmedetomidin and Ginger on post ‎operative Nausea and Vomiting in total abdominal hysterectomy.This study is ‎clinical trials and double blind.92 patient’s candidate total abdominal ‎hysterectomy will enter Taleghani hospital. We will divide in two groups ‎‎(Dexmedetomidin and Ginger).We will prescribe 1 germ Ginger before ‎anesthesia in first group and we inject 25 micro gram Dexmedetomidin slowly ‎before incision.We check Nausea and Vomiting and hydrodynamic after ‎surgery and in recovery.‎ Inclusion criteria: All patients undergoing abdominal hysterectomy; ASA class ‎I and II; no history of mental illness and psychotic; lack of history Parkinson's ‎disease, movement disorders, history of chemotherapy; general anesthesia; 35 ‎to 60 years; maximum duration of surgery 150 minutes.‎ Exclusion criteria: duration of surgery more than 150 minutes; Parkinson's ‎disease;‎ Psychotic and mental disorders; history of chemotherapy

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017051020258N47
Registration date: 2017-05-16, 1396/02/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-16, 1396/02/26
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
Recruitment complete
Funding source
Vice Chancellor and Research,Arak University of Medical Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2019-05-05, 1398/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Dexmedetomidin & Ginger on Post Operative Nausea & ‎Vomiting in total abdominal hysterectomy
Public title
Comparison of effect of Dexmedetomidin & Ginger on Post Operative Nausea & ‎Vomiting in total abdominal hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients undergoing abdominal hysterectomy; ASA class ‎I and II; no history of mental illness and psychotic; lack of history Parkinson's ‎disease, movement disorders, history of chemotherapy; general anesthesia; 35 ‎to 60 years; maximum duration of surgery 150 minutes.‎ Exclusion criteria: duration of surgery more than 150 minutes; Parkinson's ‎disease;‎
Age
From 35 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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
Postal code
38149578558
Approval date
2017-04-30, 1396/02/10
Ethics committee reference number
IR.ARAKMU.REC.1395.441

Health conditions studied

1

Description of health condition studied
total abdominal hysterectomy
ICD-10 code
Z90.7
ICD-10 code description
Acquired absence of genital organ

Primary outcomes

1

Description
Nausa and vomitting
Timepoint
after surgery and recovery
Method of measurement
clinical observation

2

Description
hymodinamic‎
Timepoint
after surgery and recovery
Method of measurement
clinical

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:we inject 25 micro gram Dexmedetomidin slowly before incision.
Category
Treatment - Drugs

2

Description
Intervention group: We will prescribe 1 germ Ginger before anesthesia in first group.
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

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 Rafiee
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Faculty, Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
alikamaliir@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Maryam Shokrpour
Position
Faculty, gynecologist
Other areas of specialty/work
Street address
Taleghani hospital, Emam Khomeini street, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
maryam_shokrpour@yahoo.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Shabnam Beigi
Position
medicine student
Other areas of specialty/work
Street address
Payambar Azam Complex, Basij Square, Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
beigi_shabnam@yahoo.com
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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