The aim of this study was determination and comparison the hemodynamic changes due to spinal anesthesia in pre-eclamptic patients and normal pregnant women during elective cesarean section. In design of the study, 35 pre-eclamptic patients and 35 normal pregnant women were selected for elective cesarean section under spinal anesthesia. Before spinal anesthesia, all patients received 8-10 ml/kg Ringer's solution. For spinal anesthesia in both groups, 2 ml bupivacaine 0.5% (10mg) and 2 ml fentanyl (20µg) were administered in subarachnoid space through the needle number 25 at the level of L4-L5 in the sitting position.
The participants of the study were pre-eclamptic or normal pregnant women between 18 and 45 years old. In the presence of patient refusal of spinal anesthesia, fetal distress, and symptom of sever pre-eclampsia (convulsion, pulmonary edema, headache, visual disturbance, impaired consciousness and coagulopathy), patients were excluded from study. Blood pressure and heart rate after spinal anesthesia were measured every 5 minutes until 30 minutes after operation in the recovery room and then were compared with each other in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304157695N3
Registration date:2013-07-23, 1392/05/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-23, 1392/05/01
Registrant information
Name
Seyedeh Masoumeh Hosseini Valami
Name of organization / entity
Qazvin University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1334 8419
Email address
smhosseiniv@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Hemodynamic Effects of Spinal Anesthesia with Bupivacaine-Fentanyl in Pre-eclamptic Versus Normal Pregnant women
Public title
Hemodynamic Changes of Spinal Anesthesia in Pre-eclampsia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with age range of 18-45 years old
Exclusion criteria:
Patient refusal of spinal anesthesia, presence of: fetal distress, convulsion, pulmonary edema, headache, visual impairment, impaired consciousness, coagulopathy, high systemic blood pressure (BP>170/110), systemic involvement (diabetes mellitus, chronic hypertension), positive history of antihypertensive drugs consumption
Age
From 18 years old to 45 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd, Qazvin
City
Qazvin
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
28/20/7241
Health conditions studied
1
Description of health condition studied
Pre-eclampsia
ICD-10 code
O14.0
ICD-10 code description
Moderate Pre-eclampsia
Primary outcomes
1
Description
Blood pressure and heart rate
Timepoint
After spinal anesthesia, every 5 minutes during operation until 30 minutes after operation in recovery period
Method of measurement
By noninvasive cardiovascular monitoring, blood pressure and heart rate were measured and recorded in questionnaire
Secondary outcomes
1
Description
Shivering
Timepoint
Recovery period
Method of measurement
By observational method (mild, moderate and sever) was determined and recorded in questionnaire
2
Description
Nausea, vomiting
Timepoint
During operation until 30 minutes after operation in recovery period
Method of measurement
By observational method (mild, moderate and sever) was determined and recorded in questionnaire
3
Description
Postoperative Pain
Timepoint
During 30 minutes after operation in recovery period
Method of measurement
By Visual Analog Scale was determined and recorded in questionnaire
4
Description
Apgar score
Timepoint
First and fifth minute
Method of measurement
By numbering method (1-10) was determined and recorded in questionnaire
Intervention groups
1
Description
In the first group (normal pregnant patients), 2 ml bupivacaine 0.5% (trademark marcaine, made in Merck factory in France) and 2 ml fentanyl (20µg) was administered intrathecally as a single dose.
Category
Prevention
2
Description
In the second group (pre-eclamptic patients), 2 ml bupivacaine 0.5% (trademark marcaine, made in Merck factory in France) and 2 ml fentanyl (20µg) was administered intrathecally as a single dose.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Seyedeh Masoumeh Hosseini Valami M.D.
Street address
Kowsar Hospital, Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Dr. Saeed Assefzadeh
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd , Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research of Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Abbas Hosseini Jahromi M.D.
Position
Anesthesiologist / Associate Professor
Other areas of specialty/work
Street address
Shahid Rajaee Hospital, Qazvin
City
Qazvin
Postal code
00982813320107
Phone
+98 28 1332 0107
Fax
Email
sahosseinij@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Masoumeh Hosseini Valami M.D.
Position
Associate Professor
Other areas of specialty/work
Street address
Kowsar Hospital, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
smhosseiniv@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Masoumeh Hosseini Valami M.D.
Position
Associate Professor
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani st, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
smhosseiniv@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)