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Maternal and neonatal effects of remifentanil in general anaesthesia for Caesarean delivery

Protocol summary

Summary
The purpose of this study was to evaluate the effects of remifentanil on hemodynamic variables in mothers, APGAR, and umbilical artery PH in neonates in the women undergoing general anesthesia for semi-elective cesarean section in Shahid Sadoughi hospital in YAZD, IRAN. In a randomized double blind trial, 80 women with term pregnancy, aged 18-35 years old, and ASA physical status I, were studied in two groups. Patients in intervention group (n=40) received an intravenous bolus of 0.5 µg/kg remifentanil whereas, women in control group (n=40) received the same dose of saline as placebo, immediately before induction of anesthesia. Maternal hemodynamic variables (systolic, diastolic, mean blood pressure, and heart rate) as well as neonatal umbilical artery PH and Apgar score at 1 and 5 min were evaluated in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102252963N2
Registration date: 2011-04-16, 1390/01/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-04-16, 1390/01/27
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2009-04-04, 1388/01/15
Expected recruitment end date
2010-04-19, 1389/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Maternal and neonatal effects of remifentanil in general anaesthesia for Caesarean delivery
Public title
Maternal and neonatal effects of remifentanil in general anaesthesia for Caesarean delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with American Society of Anesthesia (ASA) physical status I or II and singleton term pregnancies who are candidate for cesarean section that is not emergent Exclusion criteria: Anaphylaxis reaction to the anesthetic drugs, excessive bleeding during the operation
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Shahid Sadoughi University of Medical Sciences
Street address
Bahonar square
City
Yazd
Postal code
Approval date
2009-02-11, 1387/11/23
Ethics committee reference number
107532

Health conditions studied

1

Description of health condition studied
Remifentanil
ICD-10 code
Y45.0
ICD-10 code description
Opioids and related analgesics

Primary outcomes

1

Description
diastolic blood pressure
Timepoint
before of induction of general anesthesia,immediately after laryngoscopy and intubation, after incision of skin, after delivery of fetus
Method of measurement
NIBP monitoring

2

Description
systolic blood pressures
Timepoint
before of induction of general anesthesia,immediately after laryngoscopy and intubation, after incision of skin, after delivery of fetus
Method of measurement
NIBP monitoring

3

Description
mean arterial pressure
Timepoint
before of induction of general anesthesia,immediately after laryngoscopy and intubation, after incision of skin, after delivery of fetus
Method of measurement
NIBP monitoring

4

Description
heart rate in mother
Timepoint
before of induction of general anesthesia,immediately after laryngoscopy and intubation, after incision of skin, after delivery of fetus
Method of measurement
EKG monitoring

Secondary outcomes

1

Description
APGAR score in the neonate
Timepoint
1 and 5 minutes after birth
Method of measurement
APGAR score

2

Description
umblical cord PH
Timepoint
After delivery
Method of measurement
blood gas analysis

Intervention groups

1

Description
An intravenous bolus of 0.5 µg/kg remifentanil immediately before induction of anesthesia
Category
Treatment - Drugs

2

Description
The same volume of saline as remifentanil, intravenously, as placebo, immediately before induction of anesthesia
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr. Shekoufeh Behdad
Street address
Shahid Sadoughi Hospital,Yazd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Hasan Mozaffari
Street address
Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Manager of anesthesia group
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4104
Fax
Email
drbehdad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4104
Fax
Email
drbehdad@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Manager of Anesthesia group
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4104
Fax
Email
drbehdad@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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