Comparison Different Doses Of Intrathecal Dexmedetomidine On Change Of Hemodynamic Parameter And Block QualityAnd neonate’s APGAR After Spinal Anesthesia With Ropivacaine In Cesarean Section
Comparison Different Doses Of Intrathecal Dexmedetomidine On Change Of Hemodynamic Parameter And Block QualityAnd neonate’s APGAR After Spinal Anesthesia With Ropivacaine In Cesarean Section
Design
This study is clinical trial and double-blind .120 patients will enllore non-emergency cesarean section under spinal anesthesia at Taleghani hospital in Arak.
Settings and conduct
This study is clinical trial and double-blind .120 patients will enllore non-emergency cesarean section under spinal anesthesia at Taleghani hospital in Arak.We divide patients in 4 groups by block random pattern.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-35 years; ASA class I and II; patients undergoing cesarean section
Exclusion criteria:Refusal of the patient to perform spinal anesthesia; failure to perform spinal anesthesia; history of taking beta-blockers and alpha-2 agonists and calcium channel blockers; cardiovascular disease; coagulation disorders; localized infection in the spinal cord; topical infection in the history of allergy to dexmedmotidine and rupivacaine; arrhythmia
Intervention groups
We inject for patients 2/5 milliliter rupivacaine (0/5 percent(12/5 milligram) Intrathecal plus 2/5 micro gram dexmedetomidin in 1/5 milliliter in first group.
We inject 2/5 milliliter rupivacaine (0/5 percent(12/5 milligram) plus 5 micro gram dexmedetomidin in 1/5 milliliter in second group.
We inject 2/5 milliliter rupivacaine (0/5 percent(12/5 milligram) plus 7/5 micro gram dexmedetomidin in 1/5 milliliter in third group.
We inject 2/5 milliliter rupivacaine (0/5 percent(12/5 milligram) plus 1/5 milliliter normal salin in forth group.
Main outcome variables
Comparison Different Doses Of Intrathecal Dexmedetomidine On Change Of Hemodynamic Parameter And Block QualityAnd neonate’s APGAR After Spinal Anesthesia With Ropivacaine In Cesarean Section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N72
Registration date:2018-03-13, 1396/12/22
Registration timing:registered_while_recruiting
Last update:2018-03-13, 1396/12/22
Update count:0
Registration date
2018-03-13, 1396/12/22
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Different Doses Of Intrathecal Dexmedetomidine On Change Of Hemodynamic Parameter And Block QualityAnd neonate’s APGAR After Spinal Anesthesia With Ropivacaine In Cesarean Section
Public title
Comparison Different Doses Of Intrathecal Dexmedetomidine On Change Of Hemodynamic Parameter And Block QualityAnd neonate’s APGAR After Spinal Anesthesia With Ropivacaine In Cesarean Section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-35 years
ASA class I and II
Patients undergoing cesarean section
Exclusion criteria:
Refusal of the patient to perform spinal anesthesia
Failure to perform spinal anesthesia
History of taking beta-blockers and alpha-2 agonists and calcium channel blockers
Cardiovascular disease
Coagulation disorders
Localized infection in the spinal cord
Topical infection in the history of allergy to dexmedmotidine and rupivacaine
arrhythmia
Psychological problems
Fetal distress
Peripheral and central neuropathy
Symptoms for the onset of labor
Hypertension
Preeclampsia
Restriction of intrauterine growth
Contraindication of spinal anesthesia
Polyhydramnios
Macrosomia
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not aware of the treatment received.Participant and Analyzer are blind (double blind).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Intervention group: We inject for patients 2/5 milliliter rupivacaine (0/5 percent(12/5 milligram) Intrathecal plus 2/5 micro gram dexmedetomidin in 1/5 milliliter ( total volume 4 milliliter )in first group.
Category
Treatment - Drugs
2
Description
Intervention group: We inject 2/5 milliliter rupivacaine (0/5 percent(12/5 milligram) plus 5 micro gram dexmedetomidin in 1/5 milliliter ( total volume 4 milliliter )in second group.
Category
Treatment - Drugs
3
Description
Intervention group: We inject 2/5 milliliter rupivacaine (0/5 percent(12/5 milligram) plus 7/5 micro gram dexmedetomidin in 1/5 milliliter ( total volume 4 milliliter )in third group.
Category
Treatment - Drugs
4
Description
Control group: We inject 2/5 milliliter rupivacaine (0/5 percent(12/5 milligram) plus 1/5 milliliter normal salin ( total volume 4 milliliter )in forth group.