Effects of Alfentanil on Hemodynamic Changes due to Endotracheal Intubation in Elective Cesarean Section under General Anesthesia.methods:randomized clinical traial,double blinded.control group with placebo,one centeral.A:population of study patient aged 20_40 years . inclusin criteria:patient age 20_40year ; ASA 1 ;elective cesarean section.
exclusin criteria:emergency ceserean ;using antihypertensive drug;analgesic drug and psychiatric drugs. target sampel size 50,in this study patient divided randomly in two group A and B,pationt in A group first give 10 mic/kg alfentanil for premedication and patient in second group give normal salin as the same volum and maternal hemodynamic changes (systolic blood pressur ,diastolic blood pressur,heart rate)was measured befor inductin and every 2 minute until delivery and then every 5 minute to the end of surgery.also saturation of neonate with pulse oxymetry and apgar scores were measured 1dnd 5 min after birth and Bispecteral index from the beging of general anesthesia.and maternal awarness at the the end of surgery measuring up on the chech list .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012012203N1
Registration date:2013-11-09, 1392/08/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-09, 1392/08/18
Registrant information
Name
Niloufar Massoudi
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 26 3250 6961
Email address
nmasoudi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research,Gazvin University Of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Alfentanil on Hemodynamic Changes due to Endotracheal Intubation in Elective Cesarean Section under General Anesthesia
Public title
Effects of Alfentanil on Hemodynamic Changes due to Endotracheal Intubation in Elective Cesarean Section under General Anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
inclusin criteria:patient age 20_40year; ASA 1 ; elective cesarean section.
exclusin criteria:emergency ceserean; using antihypertensive drug; analgesic drug ;psychiatric drugs.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ghazvin University Of Medical Science
Street address
Ghazvin University Of Medical Science, Navab Avenue ,Ghazvin
City
Ghazvin
Postal code
3413996134
Approval date
2013-05-22, 1392/03/01
Ethics committee reference number
7410/20/28
2
Ethics committee
Name of ethics committee
Gzvin University Of Medical Science
Street address
Gzvin University Of Medical Science,Navab avenue
City
Gazvin
Postal code
Approval date
2013-05-22, 1392/03/01
Ethics committee reference number
7410/20/28
Health conditions studied
1
Description of health condition studied
Elective cesearean under general anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
heart rate
Timepoint
evey 2 minute until delivery thenevery 5 minute to the end of surgery
Method of measurement
number of heart rate in one minute
2
Description
measuring systolic and diastolic blood pressur
Timepoint
evey 2 minute until delivery thenevery 5 minute to the end of surgery
Method of measurement
with cuff of blood pressure measuring
Secondary outcomes
1
Description
Bispecteral Index
Timepoint
every 2 minute unti delivery and then every 5 minute to the end of surgery
Method of measurement
level of consciousness
2
Description
Saturation of neonate
Timepoint
after birth of neonet measuring
Method of measurement
level of oxygen in arterial blood measurig with pulse oxymetry
3
Description
apgar scor
Timepoint
1 minute and 5 after birth
Method of measurement
level of consciousness in 1and 5min after birth
4
Description
awarness
Timepoint
after awaking in recovery
Method of measurement
time of maternal recall
Intervention groups
1
Description
in interventional group patint give 10 mic/kg alfentanil befor induction
Category
Treatment - Drugs
2
Description
control group give the same volum of intervention group normal salin befor induction
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
KosarHospital Ghazvin University Of Medical Science
Full name of responsible person
nilofar masoudi
Street address
kosar hospital,Vlieasr Avenue,Gazvin
City
Ghazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research,Ghzvin University Of Medical Science
Full name of responsible person
Mahnaz abasi
Street address
Ghazvin University Of Medical science,Navab avenu, Ghazvin
City
Ghazvin
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,Ghzvin University Of Medical Science
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
Ghazvin University Of Medical Science
Full name of responsible person
Nilofar Masoudi
Position
resident of anesthesia
Other areas of specialty/work
Street address
Ghazvin University Of Medical Science,Navab Avenue,Ghazvin
City
Ghazvin
Postal code
3413996136
Phone
+98 28 1335 9557
Fax
+98 28 1333 5800
Email
nmasoudi@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gazvin University Of Medical Science
Full name of responsible person
nilofar masoudi
Position
Residet of Anesthesia
Other areas of specialty/work
Street address
Ghazvin University Of Medical Science Ghazvin,Navab avenue,Gazvin
City
Ghazvin
Postal code
3413996136
Phone
+98 28 1335 9557
Fax
+98 982813335800
Email
nmasoudi@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)