The pressor response to laryngoscopy is known to be exaggerated in patients with severe preeclampsia. The aim of the study is to compare the effects of intravenous Labetalol or remifentanil on cardiovascular responses to tracheal intubation.
Following approval from the Local Ethics Committee and receipt of written informed consent, 70 preeclamptic parturients undergoing cesarean section with general anesthesia will be randomly assigned in two groups. Group 1, will receive intravenous remifentanil 1µg/kg two min prior to induction of anesthesia (n=35), and group 2 will receive intravenous labetalol 0.25 mg/kg (n=35) before rapid sequence induction of anesthesia using thiopental 5 mg/kg and suxamethonium 1.5 mg/kg. Systolic, diastolic and mean arterial pressure, heart rate, and any type of arrhythmias will be recorded and compared between two groups at pre-induction, pre-intubation, and at 1, 3, and 5 min after intubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014022810765N5
Registration date:2014-07-25, 1393/05/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-25, 1393/05/03
Registrant information
Name
Sousan Rasooli
Name of organization / entity
Alzahra hospital/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
rasoolis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-07-02, 1393/04/11
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Hemodynamic changes due to endotracheal intubation in severe preeclamptic patients during cesarean section with General Anesthesia
Public title
Comparison of hemodynamic changes due to endotracheal intubation with labetalol and remifentanil in severe preeclamptic patients undergoing cesarean delivery with General Anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : parturients with severe preeclampsia undergoing cesarean section with general anesthesia; women with ASA class II and III; patient's written informed consent for contribute in study
Exclusion criteria: Women with ASA class IV or above; patients with severe asthema;
congestive heart failure; arrhythmia; problems with intubation
Age
From 19 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Tabriz University of Medical Sciences
Street address
Tabriz university of Medical Sciences
City
Tabriz
Postal code
Approval date
2014-07-01, 1393/04/10
Ethics committee reference number
9353
Health conditions studied
1
Description of health condition studied
complication of anesthesia
ICD-10 code
0.29-8
ICD-10 code description
Primary outcomes
1
Description
Blood Pressure
Timepoint
Pre-induction, pre-intubation, and at 1, 3, and 5 min after intubation
Method of measurement
None Invasie BP measure
Secondary outcomes
1
Description
Heart Rate
Timepoint
Pre-induction, pre-intubation, and at 1, 3, and 5 min after intubation
Method of measurement
ECG Monitoring
Intervention groups
1
Description
Patients in group 1 will be received remifentanil 1µg/kg intravenously 2 minute prior to induction of anesthesia. Then rapid sequence induction of anesthesia using thiopental 5 mg/kg and suxamethonium 1.5 mg/kg will perform.
Category
Treatment - Drugs
2
Description
Patients in group 2 will be received labetalol 0.25 mg/kg intravenously 5 minute prior to induction of anesthesia. Then rapid sequence induction of anesthesia using thiopental 5 mg/kg and suxamethonium 1.5 mg/kg will perform.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr. Sousan Rasooli
Street address
Alzahra Hospital, South Artesh Ave, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Sousan Rasooli
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Sousan Rasooli
Position
Associate Professors of Anesthesiology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
Rasooli_s@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Sousan Rasouli
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
RRasooli_s@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)