Comparison of the effects of the drug Dexmedetomidine with propofol in reducing the incidence of nausea and vomiting after gynecological laparoscopic surgery
The purpose of this study is to compare the efficacy of the drug Dexmedetomidine ,versus propofol in reducing the incidence of nausea and vomiting after gynecological laparoscopic surgery. In a randomized, double-blind, clinical trial, 64 female patients between the ages of 18 and 50 years with American Society of Anesthesia class 1 and 2. Candidate for elective laparoscopic surgery in Imam Reza Hospital in Kermanshah, and also was not aware that the methods of grouping were randomly divided into two groups: propofol and Dexmedetomidine with inclusion criteria: Female gender, fasting for eight hours and consent to participate in the study and exclusion criteria: duration of operation more than two hours and the use of anti emetics. The work will be conducted in two phases. All agreements and preparation before surgery and after surgery in both groups are same. However, induction with propofol in the propofol group and in induction of Dexmedetomidine in Dexmedetomidine group done. At the conclusion of surgery nausea and vomiting evaluate by a colleague was not aware of groups according to the questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601081617N11
Registration date:2016-09-22, 1395/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-22, 1395/07/01
Registrant information
Name
Mansour Choubsaz
Name of organization / entity
Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 83 1724 6708
Email address
mchoubsaz@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of the drug Dexmedetomidine with propofol in reducing the incidence of nausea and vomiting after gynecological laparoscopic surgery
Public title
Effects of the drug Dexmedetomidine versus propofol in reducing nausea and vomiting after gynecological surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Female gender, undergoing elective gynecologic laparoscopic surgery , fasting for eight hours, consent to participate in the study
Exclusion criteria: duration of operation more than two hours, the use of antiemetics
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly allocated to intervention and control groups is done based on random numbers table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National ethic Committee in bio medical research of Kermanshah University of Medical Sciences
Street address
National ethic Committee in bio medical research of Kermanshah University of Medical Sciences, Shaheed Beheshti Boulevard
City
Kermanshah
Postal code
6718938179
Approval date
2016-01-05, 1394/10/15
Ethics committee reference number
Kums.REC.1394.276
Health conditions studied
1
Description of health condition studied
nausea and vomiting
ICD-10 code
K91.9
ICD-10 code description
Postprocedural disorder of digestive system, unspecified
Primary outcomes
1
Description
nausea
Timepoint
thirty minutes after consciousness
Method of measurement
questionnaire
2
Description
vomiting
Timepoint
thirty minutes after consciousness
Method of measurement
questionnaire
Secondary outcomes
1
Description
----
Timepoint
---
Method of measurement
----
Intervention groups
1
Description
induction with Dexmedetomidine
One microgram/kg intravenous injection in ten minutes of drug Dexmedtomidin hydrochloride of100microgram/milliliter solution (Precedex)
Category
Prevention
2
Description
induction with propofol
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Farid Najafi
Street address
Kermanshah University of Medical Sciences, Shaheed Beheshti Boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Farid Najafi
Street address
Shaheed Beheshti Boulevard, Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah 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
Imam Reza Hospital
Full name of responsible person
Aida Lahoorpour
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesia and Intensive Care, Imam Reza Hospital ,parastar beulvard
City
Kermanshah
Postal code
6718938179
Phone
+98 83 3724 6708
Fax
+98 83 3724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesia and Intensive Care, Imam Reza Hospital ,parastar beulvard
City
Kermanshah
Postal code
6718938179
Phone
+98 83 3724 6708
Fax
+98 83 3724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesia and Intensive Care, Imam Reza Hospital ,parastar beulvard
City
Kermanshah
Postal code
6718938179
Phone
+98 83 3724 6708
Fax
+98 83 3724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)