Comparison of effects of Remifentanil and Fentanyl in blood pressure and heart rate changes due to tracheal intubation in preeclamptic pregnant women candidate for cesarean section
This study was a single blinded randomised clinical trial to compare blood pressure and heart rate changes due to tracheal intubation in preeclamptic pregnant women candidated for cesarean section under general anesthesia. total sample size was 34 (17 in two groups). Inclusion criteria: cesaraen section in preeclamptic women in 20-40 y. without any history of cardiac, pulmonary or hepatic disorders before pregnancy and no alergic drug reactions or addiction.Patients were randomly divided in two groups. after recieving adequate loading fluid , in group1 0.05 microgram/kg Remifentanil infused for 3 minutes befor induction of anesthesia and in group2 , 50 microgram(1 milliliter) Fentanyl injected and anesthesia induced after 3 minutes with Thiopental and Succynil cholin. Heart rate, systolic and diastolic blood pressure were measured automatically before opioid injection,before and after tracheal intubation. , Newborn Apgar Score was measured at birth and 5th minute after birth as a secondary outcome to evaluate the possible effects of drugs on newborn condition.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108294969N2
Registration date:2011-09-22, 1390/06/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-22, 1390/06/31
Registrant information
Name
Alireza Pournajafian
Name of organization / entity
Tehran University of Medical Sciense
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
drpournajafian@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Science
Expected recruitment start date
2007-03-21, 1386/01/01
Expected recruitment end date
2009-03-21, 1388/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of Remifentanil and Fentanyl in blood pressure and heart rate changes due to tracheal intubation in preeclamptic pregnant women candidate for cesarean section
Public title
Comparison of effects of Remifentanil and Fentanyl in blood pressure and heart rate changes due to tracheal intubation in preeclamptic pregnant women candidate for cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: pregnant women with preeclampcia, between 20 and 40 years old, candidate for elective or emergency cesarean section
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:
34
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
Tehran University of Medical Science
Street address
Next to Milad Tower, Hemmat Highway
City
Tehran
Postal code
Approval date
2007-02-04, 1385/11/15
Ethics committee reference number
4276
Health conditions studied
1
Description of health condition studied
preeclampsia
ICD-10 code
O14
ICD-10 code description
Gestational [pregnancy-induced] hypertension with significant proteinuria
Primary outcomes
1
Description
systolic blood pressure
Timepoint
before induction of anesthesia,before tracheal intubation,after tracheal intubation
Method of measurement
automatic
2
Description
diastolic blood pressure
Timepoint
before induction of anesthesia,before tracheal intubation,after tracheal intubation
Method of measurement
automatic
3
Description
heart rate
Timepoint
before induction of anesthesia,before tracheal intubation,after tracheal intubation
Method of measurement
puls oxymeter
Secondary outcomes
1
Description
apgar score of newborn
Timepoint
1st and 5th minute after birth
Method of measurement
number 1 to 10 , depending on breathing, heart rate,skin color,
Intervention groups
1
Description
injection of 0.05 microgram/kg Remifentanil during 3 minutes before induction of anesthesia
Category
Prevention
2
Description
injection of 1 mg/kg Fentanyl 3 minutes before induction of anesthesia
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Alireza Pournajafian
Street address
Beh afarin st., Karim khan Ave., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
mrs. jafarpour
Street address
Next to Blood Bank, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?