This study is aimed to evaluate the effects of two different dosages of remifentanil infusion on Apgar score of neonates and awareness of mothers during general anesthesia for elective cesarean section. This double-blind clinical trial was performed on 90 participants aged between 18 and 35 years undergoing elective cesarean section who are randomly assigned into three equal groups. The patients will receive infusion of remifentanil 0.2µg/kg/min, remifentanil 0.1µg/kg/min, or normal saline with the same volume and rate in the control group. Before infusion and just before and after tracheal intubation and 5 min after that, systolic and diastolic blood pressure and heart rates of the mothers were recorded. Apgar scores of neonates were recorded at first and 5th minutes after birth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105162883N2
Registration date:2011-05-26, 1390/03/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-26, 1390/03/05
Registrant information
Name
Mohammadreza Habibi
Name of organization / entity
Mazandarn University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 3023
Email address
mhabibi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Mazandaran University of Medical Sciences and Health Services
Expected recruitment start date
2009-12-30, 1388/10/09
Expected recruitment end date
2010-06-21, 1389/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Maternal and Neonatal Effects of two different dosages of Remifentanil at Induction of General Anesthesia for Cesarean Delivery
Public title
Effects of two different dosages of Remifentanil at Induction of General Anesthesia for Cesarean Delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women aged 18-35 years with American Society of Anesthesiologist physical status class I- II, candidate for elective cesarean section under general anesthesia
Exclusion criteria: associated disease such as preeclampsia, hypertension, history of difficult intubation, cardiovascular or respiratory disorders, diabetes
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
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
Vice chancellor for Research of Mazandaran University of Medical Sciences and Health Services
Street address
Moalem Street, Moalem Square
City
Sari
Postal code
Approval date
2009-12-30, 1388/10/09
Ethics committee reference number
88-117
Health conditions studied
1
Description of health condition studied
Complications of anaesthesia during labour and delivery
ICD-10 code
O74.2
ICD-10 code description
Complications of anaesthesia during labour and delivery
Primary outcomes
1
Description
Blood pressure of the mothers
Timepoint
Before infusion and just before and after tracheal intubation and 5 min after that-
Method of measurement
BP Monitoring
2
Description
Heart rates of the mothers.
Timepoint
Before infusion and just before and after tracheal intubation and 5 min after that
Method of measurement
ECG Monitor and pulseoxymetry
3
Description
Apgar score of neonates
Timepoint
At the first and 5th minutes after birth
Method of measurement
by the pediatrician coinvestigator
Secondary outcomes
empty
Intervention groups
1
Description
Control group: normal saline will be infused by the same volume and rate
Category
Placebo
2
Description
Intervention group A: infusion of remifentanil 0.2µg/kg/min
Category
Treatment - Drugs
3
Description
Intervention group B: infusion of remifentanil 0.1µg/kg/min
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital, Amir Mazandarani boulevard
Full name of responsible person
Mohammadreza Habibi MD.
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellor of Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Ahmadali Enayati
Street address
Moalem street- Moalem square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellor of Mazandaran University of Medical Sciences and Health Services
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Habibi
Position
Associate Professor of Anesthesiology, member of faculty,
Other areas of specialty/work
Street address
Department of Anesthesiology, Imam Khomeini hospital, Amir Mazandarani boulevard
City
Sari
Postal code
Phone
+98 15 1226 1704
Fax
Email
MHabibi@mazums.ac.ir mohammadrezahabibi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Mohammadreza Habibi
Position
Associate Professor of Anesthesiology, Member of Faculty
Other areas of specialty/work
Street address
Department of Anesthesiology, Imam Khomeini hospital, Amir Mazandarani boulevard
City
Sari
Postal code
Phone
+98 911 111 0034
Fax
Email
MHabibi@mazums.ac.ir mohammadrezahabibi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Mohammadreza Habibi
Position
Associate Professor of Anesthesiology, Member of Faculty
Other areas of specialty/work
Street address
Department of Anesthesiology, Imam Khomeini hospital, Amir Mazandarani boulevard
City
Sari
Postal code
Phone
Fax
Email
MHabibi@mazums.ac.ir mohammadrezahabibi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)