The objective of this study is to compare clonidine and magnesium sulfate on depth of anesthesia during cesarean section under general anesthesia.In this clinical trial, 120 patients with ASA I who are candidate for cesarean section , are randomly allocated into 3 groups.
In the first group, the samples are required to take one clonidine tablet 0.2 milligram one- hour prior to induction of anesthesia.
In the second group, samples will be given magnesium sulfate 30mg per kg solved in 100 milliliter normal saline during 10 minutes prior to induction of anesthesia.The first and third(control) groups will be given 100 milliliter normal saline(placebo) during 10 minutes prior to induction of anesthesia.
Then, the depth of anesthesia, blood pressure and heart rate of the patients are measured and recorded after anesthesia induction, after intubation and after the delivery of neonate. Also, postoperative recall of events occuring during anesthesia is recorded with 24 hours after operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013021112425N1
Registration date:2014-03-12, 1392/12/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-12, 1392/12/21
Registrant information
Name
Maryam Hamidi shad
Name of organization / entity
Kasahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1531 8227
Email address
hamidishad@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan Univercity of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Clonidine and magnesium sulfate on depth of anesthesia during cesarean section under general anesthesia
Public title
The comparison of Clonidine and magnesium sulfate on depth of anesthesia during cesarean section under general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion critria : pregnant women; ASA-1; elective cesarean section
exclusion critria: hypertention; diabet; renal disease; cardiovascular disease; preeclampsy; allergy of clonidine or magnesiom sulfate; using of antiepileptic drug; difficult intubation; depression or other psycological disease.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
5th Km of Ghotbe Ravandi Bulv.
City
Kashan
Postal code
Approval date
2012-11-22, 1391/09/02
Ethics committee reference number
3159/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Depth of anesthesia
ICD-10 code
Y84
ICD-10 code description
Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Depth of anesthesia
Timepoint
After induction,after intubation,after delivery
Method of measurement
With cerebral state monitoring device
Secondary outcomes
1
Description
Awareness
Timepoint
The day after surgery
Method of measurement
Question
Intervention groups
1
Description
Group 1:tab clonidine 0/2 mg ,1hour befor induction and infusion of 100 cc normal saline(placebo) ,during 10 minutes befor induction of anesthesia
Category
Treatment - Drugs
2
Description
Group 2:Sulfate Magnesiom 30 mg/kg that is solued in 100 cc normal saline will be given during 10 minutes
Category
Treatment - Drugs
3
Description
Group 3:control group,that will be given 100 cc normal saline(placebo) during 10 minutes befor induction of anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shabihkhani Hospital
Full name of responsible person
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
5th Kilometer Ghotbe Ravandi Bulv.Kashan University of Medical Sciences
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Kashan 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
kashan University of Medical Sciences
Full name of responsible person
Maryam Hamidi Shad
Position
Assistant of anesthesiology
Other areas of specialty/work
Street address
5th Kilometer Ghotbe Ravandi Bulv
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
maryamhamidishad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Mehdi Raghabi
Position
Anesthesiologist
Other areas of specialty/work
Street address
5th Kilometer Ravand Bulv.
City
Kashan
Postal code
Phone
+98 36 1557 8145
Fax
Email
mrajabi52@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan Univercity of Medical Sciences
Full name of responsible person
Maryam Hamidi Shad
Position
Other areas of specialty/work
Street address
5th Kilometer Ghotbe Ravandi Bulvar
City
Kashan
Postal code
8715988141
Phone
+98 36 1555 0026
Fax
+98 36 1557 5057
Email
maryamhamidishad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)