Comparison effect of intravascular administration of colloid
versus crystalloid in prevention of hypotension after spinal anesthesia for cesarean section
purpose: Comparison of fluid therapy and its effect on the prevention of maternal hypotension in pregnant women ASA I-II who are under spinal anesthesia for elective cesarean section. Design and criteria: This study is prospective, randomized, not-blinded and clinical trial.
Setting and conduct: 100 patients scheduled for elective cesarean section under spinal anesthesia were randomly placed into four groups. 7 cc/kg colloid is given before and colloid with spinal anesthesia in group 1 and 2 , respectively, 10 cc/kg of crystalloid is given before and colloid with spinal anesthesia in group 3 and 4 , respectively. Vital signs are checked befor and every 3 minutes to initial 10 minutes after spinal anesthesia and then every 5 minutes
until recovery.
Inclusion criteria: Candidates for elective cesarean surgery; ASA I-II; 18-40 years old. Exclusion criteria: Patients who received intravenous fluids before entering the operating room; BMI≥30; ASA>3; Age less than 18 years and more than 40 years; Contraindications to spinal anesthesia procedures; Emergency cesarean section; Amount of intraoperative bleeding over 1000cc; History of hypertension and blood pressure in pregnancy; instances may increase the risk of bleeding and inertia. Main outcome: Primary outcomes; blood pressure and heart rate changes. Secondary outcomes; nausea & Vomiting, Chest discomfort, neonate apgar, Efedrin require. Intervention: Group1 ; Colloid recipient, 20 min before spinal anesthesia. Group 2 ; receiving Colloid while spinal anesthesia. Control group 1 ; Crystalloid recipient, 20 min before spinal anesthesia. Control group 2 ; Received spinal anesthesia with crystalloid.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013051612094N2
Registration date:2013-06-29, 1392/04/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-29, 1392/04/08
Registrant information
Name
Majid Razavi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 110 8630
Email address
razavim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Science
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of intravascular administration of colloid
versus crystalloid in prevention of hypotension after spinal anesthesia for cesarean section
Public title
Effect of fluid therapy in reducing complications of spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Candidates for elective cesarean surgery; ASA I-II; 18-40 years old.
Exclusion criteria: Patients who received intravenous fluids before entering the operating room; BMI≥30; ASA>3; Age less than 18 years and more than 40 years; Contraindications to spinal anesthesia procedures; Emergency cesarean section; Amount of intraoperative bleeding over 1000cc; History of hypertension and blood pressure in pregnancy; Instances may increase the risk of bleeding and inertia.
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
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 Mashhad University of Medical Sciences
Street address
Ghoreishi apartment, Daneshgah st, Mashhad
City
Mashhad
Postal code
Approval date
2012-09-19, 1391/06/29
Ethics committee reference number
910046
Health conditions studied
1
Description of health condition studied
Spinal anesthesia
ICD-10 code
O29.5
ICD-10 code description
Other complications of spinal and epidural anaesthesia during pregnancy
Primary outcomes
1
Description
Blood pressure changes
Timepoint
Befor spinal, every 3 minutes to initial 10 minutes, and then every 5 minutes until recovery.
Method of measurement
Perioperative monitoring
2
Description
Heart rate changes
Timepoint
Befor spinal, every 3 minutes to initial 10 minutes, and then every 5 minutes until recovery.
Method of measurement
Perioperative monitoring
Secondary outcomes
1
Description
Nausea & Vomiting
Timepoint
Postoperative time
Method of measurement
Clinical observation
2
Description
Chest discomfort
Timepoint
Duration of Surgery
Method of measurement
Recorded in the questionnaire
3
Description
Neonate apgar
Timepoint
Duration of Surgery
Method of measurement
Recorded in the questionnaire
4
Description
Efedrin require
Timepoint
Duration of Surgery
Method of measurement
Recorded in the questionnaire
Intervention groups
1
Description
Intervention group1 : Colloid infusion, 20 minutes before spinal anesthesia
Category
Prevention
2
Description
Intervention group 2 : colloid infusion with spinal anesthesia
Category
Prevention
3
Description
Control group1 : crystalloid infusion, 20 min before spinal anesthesia
Category
Prevention
4
Description
control group 2 : crystalloid infusion with spinal anesthesia
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Majid Razavi
Street address
Department of Anesthesiology, Imam Reza Hospital, Ibne Sina st, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
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, Mashhad University of Medical Science
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
Mashhad University of Medical Sciences
Full name of responsible person
Majid Razavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina st, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5029
Fax
Email
Razavim@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Majid Razavi
Position
Assistan Professor
Other areas of specialty/work
Street address
Deparment of Anestesia, Imam Reza Hospital, Ibne Sina st, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5029
Fax
Email
Majidm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Razavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5029
Fax
Email
razavim@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)