Protocol summary

Summary
The aim of this clinical trial was evaluation the efficacy of six combinational methods for preventing maternal hypotension after spinal anesthesia for cesarean delivery. A total of 300 ASA physical status I-II women undergoing elective cesarean section with spinal anesthesia were randomized to six groups: 1-Ringer's lactate (RL) solution (15 ml/kg) and colloid (Hemaxel) preload (7ml/kg); 2- RL solution preload (15 ml/kg) and ephedrine(15 mg, IV, bolus); 3-RL solution preload (15 ml/kg) and leg bandage; 4-Colloid (Hemaxel) preload (7ml/kg) and ephedrine(15 mg, IV, bolus); 5-Colloid (Hemaxel) preload (7ml/kg) and leg bandage; 6-Ephedrine (15 mg, IV, bolus)and leg bandage.The crystalloid and colloid solution infused 30 minutes before spinal anesthesia and ephedrine and leg bandage administered immediately after spinal anesthesia in above groups.Spinal anesthesia was done using bupivacaine 0.5 percent 2.5 ml in all patients. Participants were including parturients with ASA physical status I-II, scheduled for elective cesarean section, under spinal anesthesia and excluded with suspicious to bleeding disturbances, atopia, diabetes mellitus, presence of liver or kidney diseases, drugs abuse, hypertension of pregnancy, preeclampsia. Maternal blood pressure and heart rate compared on arrival to operating room, immediately after anesthesia (time 0), and minutes 3, 5, 15, 20, 25, 30, 35, and 60 after spinal injection among the groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107062405N7
Registration date: 2011-07-13, 1390/04/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-07-13, 1390/04/22
Registrant information
Name
Mitra Jabalameli
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7472
Email address
jabalameli@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2004-05-31, 1383/03/11
Expected recruitment end date
2008-02-11, 1386/11/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of different prophylactic techniques in hypotension due to spinal anesthesia on blood pressure and heart rate of parturients undergoing cesarean section
Public title
The comparison of different prophylactic techniques in hypotension due to spinal anesthesia on mother"s hemodynamic changes and neonatal outcome in cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Parturients; ASA physical status I-II; scheduled for elective cesarean section; under spinal anesthesia; Exclusion Criteria: suspicious to bleeding disturbances; atopia; diabetes mellitus; presence of liver or kidney diseases; drugs abuse; hypertension of pregnancy; preeclampsia
Age
From 15 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 300
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, Ethics committee of Isfahan University of Medical Sciences
Street address
Vice-chancellor for Research, Isfahan University of Medical Sciences
City
Isfahan
Postal code
00
Approval date
2004-05-31, 1383/03/11
Ethics committee reference number
83036

Health conditions studied

1

Description of health condition studied
Complications of anaesthesia during pregnancy
ICD-10 code
O29.8
ICD-10 code description
Other complications of anaesthesia during pregnancy

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
On arrival to operating room, immediately after anesthesia (time 0), and minutes 3, 5, 15, 20, 25, 30, 35, and 60 after spinal injection
Method of measurement
Using mercury manometer

2

Description
Heart rate
Timepoint
On arrival to operating room, immediately after anesthesia (time 0), and minutes 3, 5, 15, 20, 25, 30, 35, and 60 after spinal injection
Method of measurement
Using EKG Monitoring

Secondary outcomes

1

Description
Apgar score
Timepoint
at min 1 and 5
Method of measurement
Apgar score mesurements by physical examination

2

Description
NACS
Timepoint
at 15 minutes, 2 hours, and 24 hours after delivery
Method of measurement
NACS mesurements by physical examination

Intervention groups

1

Description
Ringer's lactate (RL) solution (15 ml/kg) was infused. Duration of treatment: single dose in 30 minutes before spinal injection + mid thigh-high lower extremities bandage was performed immediately after spinal injection. Duration of treatment: During spinal anesthesia in operating room
Category
Prevention

2

Description
Colloid solution (Hemaxel) (7ml/kg) was infused. Duration of treatment: single dose in 30 minutes before spinal injection + mid thigh-high lower extremities bandage was performed immediately after spinal injection. Duration of treatment: During spinal anesthesia in operating room
Category
Prevention

3

Description
Ephedrine (15 mg, IV, bolus) was infused in 45 seconds. Duration of treatment: single dose Immediately after spinal injection+ mid thigh-high lower extremities bandage was performed immediately after spinal injection. Duration of treatment: During spinal anesthesia in operating room
Category
Prevention

4

Description
Ringer's lactate (RL) solution (15 ml/kg) was infused. Duration of treatment: single dose in 30 minutes before spinal injection + colloid solution (Hemaxel) (7ml/kg) was infused. Duration of treatment: single dose in 30 minutes before spinal injection
Category
Prevention

5

Description
Ringer's lactate (RL) solution (15 ml/kg) was infused. Duration of treatment: single dose in 30 minutes before spinal injection + Ephedrine (15 mg, IV, bolus) was infused in 45 seconds. Duration of treatment: single dose Immediately after spinal injection
Category
Prevention

6

Description
Colloid solution (Hemaxel) (7ml/kg) was infused. Duration of treatment: single dose in 30 minutes before spinal injection + Ephedrine (15 mg, IV, bolus) was infused in 45 seconds. Duration of treatment: single dose Immediately after spinal injection
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Medical Center
Full name of responsible person
Dr. Mitra Jabalameli
Street address
Department of Anesthesia and intensive care, Alzahra General Hospital, Sofe Boulevard
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research- Isfahan University of Medical Sciences
Full name of responsible person
Dr. Payman Adibi
Street address
Vice-chancellor for Research, Isfahan University of Medical Sciences- Hezar Jarib St.
City
Isfahan
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- Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mitra Jabalameli
Position
Specialist and Associate professor of Anesthesia and intensive care
Other areas of specialty/work
Street address
Department of Anesthesia and intensive care, Alzahra General Hospital, Sofe Boulevard
City
Isfahan
Postal code
Phone
+98 31162555551532
Fax
Email
jabalameli@med.mui.ac.ir
Web page address
www.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mitra Jabalameli
Position
Specialist and Associate professor of Anesthesia and intensive care
Other areas of specialty/work
Street address
Department of Anesthesia and intensive care, Alzahra General Hospital, Sofe Boulevard
City
Isfahan
Postal code
Phone
+98 31162555551532
Fax
Email
jabalameli@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mitra Jabalameli
Position
Specialist and Associate professor of Anesthesia and intensive care
Other areas of specialty/work
Street address
Department of Anesthesia and intensive care, Alzahra General Hospital, Sofe Boulevard
City
Isfahan
Postal code
Phone
Fax
Email
jabalameli@med.mui.ac.ir
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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