In this study, 90 healthy women who candidate for elective cesarean section delivery randomly divided in tow case and control group. The case group received 2 microgram per kilogram fentanyl intravenously or an equal volume of intravenous saline in control group at 2 minutes before general anesthesia. 2 minutes later the induction of anesthesia was performed with sodium thiopental 5 milligram per kilogram and succinylcholine 1.5 milligram per kilogram. After confirmation the tracheal intubation surgery was started. Fetal outcome measures included Apgar scores evaluate by blind anesthesiologist in one and five minute after berth and noted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010320112N3
Registration date:2015-01-25, 1393/11/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-25, 1393/11/05
Registrant information
Name
Pooya Derakhshan
Name of organization / entity
Birjand Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1410
Email address
pooya_derakhshan@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of fentanyl as a anesthesia induction drug on fetal apgar score in cesarean section delivery.
Public title
effect of fentanyl in anesthesia for cesarean section.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women who candidate for cesarean section; age between 20 to 35 year old; American association of anesthesiologist class 1 and 2.
Exclusion criteria: Cardiopulmonary disease; renal disease; hypertension; opium and other drug abusers; difficult intubation.
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Birjand University of Medical Sciences
Street address
N:56, Ghafari Ave.
City
Birjand
Postal code
1973456783421589
Approval date
2010-10-16, 1389/07/24
Ethics committee reference number
1389-67-90
Health conditions studied
1
Description of health condition studied
Delivery by elective caesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
apgar score
Timepoint
first and fifth minutes after berth
Method of measurement
apgar score scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
Every 3 minutes
Method of measurement
sphygmomanometer
Intervention groups
1
Description
Injection of 2 microgram per kilogram fentanyl in intervention group.
Category
Treatment - Drugs
2
Description
Injection of 2 milliliter of ringer in control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Pooya Derakhshan
Street address
Imam Reza Hostipal, Taleghani St.
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hasan Karbasi
Street address
Ghafari Ave.
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Taleghani St.
City
Birjand
Postal code
9717913873
Phone
+98 563222600
Fax
+98 563222300
Email
pooyaderkh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Talegani St.
City
Birjand
Postal code
Phone
+98 563222600
Fax
Email
pooyaderakh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Taleghani St.
City
Birjand
Postal code
9717913873
Phone
+98 563222600
Fax
+98 563222300
Email
pooyaderakh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)