Comparison of spinal anesthesia with Low & Conventional Bupivacaine dose On blood Pressure changes in severe Preeclamptic patients Candidate for cesarean section
Objective: Comparison of Low & Conventional Bupivacaine dose on blood Pressure changes in severe Preeclamptic patients Candidate for cesarean section under spinal anesthesia.
Design and setting: a randomized block design, clinical trial study, double-blind, single center, clinical trial phase 2, 60 samples
Inclusion criteria: Patients with severe preeclampsia and candidate for caesarian section under spinal anesthesia; ASA I or II; Platelets greater than or equal to 100000.
Exclusion criteria: Failure in spinal anesthesia; Heart failure; Active bleeding; History of renal or hepatic failure.
Interventions: Group 1 receive lower dose of Bupivacaine 0.5 %( 7.5 mg), and group 2 receive conventional dose of Bupivacaine 0.5 %( 12.5 mg).
Main outcome measures: Vital signs, systolic and diastolic blood pressure and Mean arterial pressure check, before and after spinal anesthesia and every 5 minutes until end of operation. Apgar scores check at first and 5th minutes after birth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091714056N9
Registration date:2016-09-27, 1395/07/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-27, 1395/07/06
Registrant information
Name
Hesameddin Modir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 9680
Email address
he_modir@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2016-05-23, 1395/03/03
Expected recruitment end date
2016-10-24, 1395/08/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of spinal anesthesia with Low & Conventional Bupivacaine dose On blood Pressure changes in severe Preeclamptic patients Candidate for cesarean section
Public title
Comparison of Low & Conventional Bupivacaine dose On blood Pressure changes in severe Preeclamptic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with severe preeclampsia and candidate for caesarian section under spinal anesthesia; ASA I or II; Platelet greater than or equal to 100000; No History of sensitivity to the local anesthetic drug.
Exclusion criteria: Failure in spinal anesthesia; Uncooperative patient in determining the sensory level; Heart failure; Active bleeding; History of renal or hepatic failure; Intracranial hemorrhage or stroke; Neurologic diseases; Psychiatric disorders(Schizophrenia; schizoaffective disorder; schizophreniform disorder; Bipolar disorder); ASA greater than or equal 3
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran.
City
Arak
Postal code
Approval date
2016-05-23, 1395/03/03
Ethics committee reference number
IR.ARAKMU.REC.1395.91
Health conditions studied
1
Description of health condition studied
severe preeclampsia
ICD-10 code
O14.1
ICD-10 code description
Severe pre-eclampsia
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
before and after spinal anesthesia and every 5 minutes until end of operation
Method of measurement
sphygmomanometer
2
Description
Diastolic blood pressure
Timepoint
before and after spinal anesthesia and every 5 minutes until end of operation
Method of measurement
sphygmomanometer
3
Description
Mean arterial pressure
Timepoint
before and after spinal anesthesia and every 5 minutes until end of operation
Method of measurement
sphygmomanometer
4
Description
Pulse rate
Timepoint
before and after spinal anesthesia and every 5 minutes until end of operation
Method of measurement
pulse rate per minute
5
Description
Oxygen saturation
Timepoint
before and after spinal anesthesia and every 5 minutes until end of operation
Method of measurement
Puse oximeter
Secondary outcomes
1
Description
Apgar score
Timepoint
at 1 and 5 minutes after birth
Method of measurement
Questionare
Intervention groups
1
Description
Intervention: Group 1 receive lower dose of Bupivacaine 0.5 %( 7.5 mg).
Category
Treatment - Drugs
2
Description
Control: Group 2 receive conventional dose of Bupivacaine 0.5 %( 12.5 mg)