Ignite Creation Date:
2024-07-17 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498076
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-13
Brief Title:
Management of Postspinal Anesthesia Hypotension During Elective Cesarean Section Baby Norepinephrine Versus Ephedrine
Sponsor:
Hopital Charles Nicolle
Organization:
Hopital Charles Nicolle
Study Overview
Official Title:
Management of Postspinal Anesthesia Hypotension During Elective Cesarean Section Baby Norepinephrine Versus Ephedrine
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Spinal anesthesia emerges as the preferred anesthesia technique for elective cesarean section It offers a preferable alternative to general anesthesia because it provides better maternal safety and neonatal outcomes However spinal anesthesia is not free of inherent risks Hypotension remains the most common complication which threats both mother and child The common method of treating hypotension includes fluid loading and the use of vasopressors such as ephedrine and phenylephrine One promising approach is the administration of diluted norepinephrine It presents a good alternative to preserve maternal blood pressure while minimizing adverse effects on the mother and fetus Thus our study proposes to evaluate the efficacy and safety of diluted norepinephrine boluses compared with ephedrine on the management of post- spinal anesthesia hypotension during scheduled cesarean sections
Patients and methods After local Ethical Commitee approval this prospective randomized double -blind study will be undertaken from August to October 2024 in the Department of Anesthesiology and Intensive care and Gynecology and Obstetric department of Charles Nicolle Hospital of Tunis After obtaining informed written consent singleton full-term pregnant females of ASA grade II aged 18-38 years scheduled for elective cesarean section under spinal anesthesia will be randomly divided into two groups Group N patients receive norepinephrine boluses 8 µg prophylactic bolus immediately after spinal anesthesia induction and therapeutic boluses when systolic blood pressure falls to 20 of baseline Group E parturients receive ephedrine boluses 6 mg systematic bolus after the induction of spinal anesthesia and therapeutic boluses if hypotension Heart rate systolic diastolic and mean blood pressure are monitored Number of episodes of hypotension and number of vasopressor boluses used in each group are recorded and considered as the primary outcomes of the study Complication during the surgery as incidence of hypertension tachycardia bradycardia nausea and vomiting are recorded We also record neonatal APGAR score at 1 minute and five minutes These parameters are considered as the secondary outcomes of the study
Statistical study
Data entry and analysis will be performed by SPSS software version 250 We will use Excel 2019 software to edit the charts Continuous quantitative variables following a normal distribution will be expressed by their means and standard deviation Categorical variables will be expressed as frequencies and percentages Analytical study Well use the Pearson chi2 test or Fischers exact test whichever appropriate for the comparison of categorical variables T test of Student and Mann Whitney U-test will be employed for comparing Continuous variables We ll retain a significance threshold for p less than 5
Patients and methods After local Ethical Commitee approval this prospective randomized double -blind study will be undertaken from August to October 2024 in the Department of Anesthesiology and Intensive care and Gynecology and Obstetric department of Charles Nicolle Hospital of Tunis After obtaining informed written consent singleton full-term pregnant females of ASA grade II aged 18-38 years scheduled for elective cesarean section under spinal anesthesia will be randomly divided into two groups Group N patients receive norepinephrine boluses 8 µg prophylactic bolus immediately after spinal anesthesia induction and therapeutic boluses when systolic blood pressure falls to 20 of baseline Group E parturients receive ephedrine boluses 6 mg systematic bolus after the induction of spinal anesthesia and therapeutic boluses if hypotension Heart rate systolic diastolic and mean blood pressure are monitored Number of episodes of hypotension and number of vasopressor boluses used in each group are recorded and considered as the primary outcomes of the study Complication during the surgery as incidence of hypertension tachycardia bradycardia nausea and vomiting are recorded We also record neonatal APGAR score at 1 minute and five minutes These parameters are considered as the secondary outcomes of the study
Statistical study
Data entry and analysis will be performed by SPSS software version 250 We will use Excel 2019 software to edit the charts Continuous quantitative variables following a normal distribution will be expressed by their means and standard deviation Categorical variables will be expressed as frequencies and percentages Analytical study Well use the Pearson chi2 test or Fischers exact test whichever appropriate for the comparison of categorical variables T test of Student and Mann Whitney U-test will be employed for comparing Continuous variables We ll retain a significance threshold for p less than 5
Detailed Description:
Background Spinal anesthesia emerges as the preferred anesthesia technique for elective cesarean section It offers a preferable alternative to general anesthesia because it provides better maternal safety and neonatal outcomes However spinal anesthesia is not free of inherent risks Among the feared complications hypotension remains the most common complication which threats both mother and child In this perspective several preventive and curative means have been studied to optimize maternal and fetal homeostasis The common methods include fluid loading and the use of vasopressors such as ephedrine and phenylephrine One promising approach is the administration of diluted norepinephrine Due to its low agonist activity of the ß receptor and its powerful α adrenergic agonist activity it presents a good alternative to preserve maternal blood pressure while minimizing adverse effects on the mother and fetus Thus our study proposes to evaluate the efficacy and safety of diluted norepinephrine boluses compared with ephedrine on the management of post- spinal anesthesia hypotension during scheduled cesarean sections
Patients and methods After approval from the Local Ethical Commitee of the Hospital N FWA 00032748 and after obtaining informed written consent this prospective randomized double -blind study will be undertaken from August to October 2024 in the Department of Anesthesiology and Intensive care and Gynecology and Obstetric department of Charles Nicolle Hospital of Tunis
Inclusion criteria Singleton full-term consenting pregnant females of ASA grade II aged 18-38 years scheduled for elective cesarean section under spinal anesthesia are included in the study
Non inclusion criteria Any parturient falling in the category ASA grade III and IV contraindications to spinal anesthesia preeclampsia chronic hypertension comorbidity with diabetes mellitus cardiovascular disorders and psychiatric illness are non included
Exclusion criteria They are excluded the case of failure of spinal anesthesia conversion to general anesthesia post-partum bleeding and failure to follow protocol
Patient groups
Sample size It was calculated by httpsstatulatorcomSampleSizess2Mhtml by adjusting a power of 80 confidence level of 95 and margin of error of 5 The primary outcome variable of our study is to compare the number of vasopressor boluses to maintain mean blood pressure 80 between the groupes which was estimated from the study conducted by Elnabtity and Selim The least number of patients required in each groupe with a standard deviation of 2 is 63
A total of 126 parturients are randomly divided into two equal groups by an investigator not directly linked to the study
Group N patients will received norepinephrine boluses 8 µg prophylactic bolus immediately after spinal anesthesia induction and therapeutic boluses when systolic blood pressure falls to 20 of baseline Group E parturients will received ephedrine boluses 6 mg systematic bolus after the induction of spinal anesthesia and therapeutic boluses if hypotension
The syringes will be labeled as syringe A and syringe B and the anesthesiologist who will give the bolus cannot know if it is ephedrine or norepinephrine
The preparation of diluted norepinephrine is done by two dilutions first dilution 1ml of norepinephrine 2 mgml is diluted to 50 ml with 09 normal saline to have a concentration of 40 µgml The second dilution 1ml of norepinephrine 40µgml is diluted to 10 ml with 09 normal saline in 10 ml syringe prepared as final concentration of 4 µgml
Ephedrine is prepared in 10 ml syringe at a concentration of 3 mgml Preoperative period A preanesthesia consultation is performed for patients included in the protocol The modalities of the young preoperative the anesthetic technique the protocol of the study are explained to the parturients Written and signed informed consent by the patients included in the study is obtained
Intraoperative setting On arrival to the operating room after a Check list The parturient is positioned on the operating table in the supine position with left uterine displacement We use a standard monitoring including non invasive blood pressure NIBP pulse oxymeter SpO2 and electrocardiogram ECG We record three values of systolic diastolic and mean blood pressure and heart rate before any patient stimulation An intravenous canula 18 G is inserted and antibiotic prophylaxis is administered 30 minutes before surgical incision using 2 g of cefazolin or 900 mg of clindamycin in case of allergy to penicillins
Induction of spinal anesthesia Co fluid loading 10 ml kg of crystalloids is commenced In the sitting position under all aseptic precautions introduction of spinal needle 25 gauge at L3-L4 or L4-L5 vertebral interspace After obtaining free flow of cerebrospinal fluid a standard mixture of anesthetic product 10 mg of hyperbaric bupivacaine 05 08 mg if parturients size 160 cm with 25 µg of sufentanil and morphine 01 mg is injected After intrathecal injection parturients take quickly their initial position and the first prophylactic bolus of the vasopressor 2 ml from syringe A or syringe B is administerated Oxygen is administred by ventimask at rate of 3 lmin till the delivery of the baby The level of sensory block is evaluated by pin prick test Successful sensory block is defined as block reaching T4 dermatomal level If after 20 minutes the sensory block level remains T10 a conversion to general anesthesia is performed and the patient is excluded from the study
Heart rate systolic diastolic and mean blood pressure are recorded every minute for the first 15 minutes after spinal anesthesia and every five minutes until the end of the intervention
Management of hypotension When systolic blood pressure SBP decreases to 20 of baseline a rescue bolus of vasopressor 2 ml of syringe A or syringe B is given Reinjection of the same bolus is repeated after 1 minute if hypotension persists Administration of boluses is stopped when the value of the SBP finds 80 of the baseline
After clamping of the umbilical cord Oxytocin is given as an initial bolus of 10 UI over 3 minutes followed by slow infusion of 15 UI in 09 normal saline Neonatal APGAR score at 1 minute and five minutes is recorded
Primary outcome Number of vasopressor boluses used in each group to treat hypotension SBP decreases to 20 of baseline is recorded
Secondary outcomes Complication during the surgery as incidence of hypertension SBP 20 of baseline tachycardia Heart rate HR 120 beatsmin bradycardia HR 60 beatsmin nausea and vomiting are recorded Well also recorded neonatal APGAR score of the first and 5th minute
Statistical study
Data entry and analysis will be performed by SPSS version 250 software We will use Excel 2019 software to edit the charts Descriptive study Continuous quantitative variables following a normal distribution will be expressed by their means and standard deviation Continuous quantitative variables not following a normal law will be expressed by their median and interquartile 25-75 Qualitative variables will be expressed as simple frequencies n and relative frequencies as a percentage Analytical study For the analysis of the association between two qualitative variables we will use the Pearson chi-2 test for the comparison of two frequencies under verified application conditions and the Fischer test otherwise For the analysis of the association between a qualitative variable and a quantitative variable we ll use the T test of Student for the comparison of two means and the non-parametric test of Mann Whitney otherwise We ll retain a significance threshold for p 5 In the multivariate study risk will be calculated by the Odds Ratio OR with a retained confidence interval of 95 95 CI
Patients and methods After approval from the Local Ethical Commitee of the Hospital N FWA 00032748 and after obtaining informed written consent this prospective randomized double -blind study will be undertaken from August to October 2024 in the Department of Anesthesiology and Intensive care and Gynecology and Obstetric department of Charles Nicolle Hospital of Tunis
Inclusion criteria Singleton full-term consenting pregnant females of ASA grade II aged 18-38 years scheduled for elective cesarean section under spinal anesthesia are included in the study
Non inclusion criteria Any parturient falling in the category ASA grade III and IV contraindications to spinal anesthesia preeclampsia chronic hypertension comorbidity with diabetes mellitus cardiovascular disorders and psychiatric illness are non included
Exclusion criteria They are excluded the case of failure of spinal anesthesia conversion to general anesthesia post-partum bleeding and failure to follow protocol
Patient groups
Sample size It was calculated by httpsstatulatorcomSampleSizess2Mhtml by adjusting a power of 80 confidence level of 95 and margin of error of 5 The primary outcome variable of our study is to compare the number of vasopressor boluses to maintain mean blood pressure 80 between the groupes which was estimated from the study conducted by Elnabtity and Selim The least number of patients required in each groupe with a standard deviation of 2 is 63
A total of 126 parturients are randomly divided into two equal groups by an investigator not directly linked to the study
Group N patients will received norepinephrine boluses 8 µg prophylactic bolus immediately after spinal anesthesia induction and therapeutic boluses when systolic blood pressure falls to 20 of baseline Group E parturients will received ephedrine boluses 6 mg systematic bolus after the induction of spinal anesthesia and therapeutic boluses if hypotension
The syringes will be labeled as syringe A and syringe B and the anesthesiologist who will give the bolus cannot know if it is ephedrine or norepinephrine
The preparation of diluted norepinephrine is done by two dilutions first dilution 1ml of norepinephrine 2 mgml is diluted to 50 ml with 09 normal saline to have a concentration of 40 µgml The second dilution 1ml of norepinephrine 40µgml is diluted to 10 ml with 09 normal saline in 10 ml syringe prepared as final concentration of 4 µgml
Ephedrine is prepared in 10 ml syringe at a concentration of 3 mgml Preoperative period A preanesthesia consultation is performed for patients included in the protocol The modalities of the young preoperative the anesthetic technique the protocol of the study are explained to the parturients Written and signed informed consent by the patients included in the study is obtained
Intraoperative setting On arrival to the operating room after a Check list The parturient is positioned on the operating table in the supine position with left uterine displacement We use a standard monitoring including non invasive blood pressure NIBP pulse oxymeter SpO2 and electrocardiogram ECG We record three values of systolic diastolic and mean blood pressure and heart rate before any patient stimulation An intravenous canula 18 G is inserted and antibiotic prophylaxis is administered 30 minutes before surgical incision using 2 g of cefazolin or 900 mg of clindamycin in case of allergy to penicillins
Induction of spinal anesthesia Co fluid loading 10 ml kg of crystalloids is commenced In the sitting position under all aseptic precautions introduction of spinal needle 25 gauge at L3-L4 or L4-L5 vertebral interspace After obtaining free flow of cerebrospinal fluid a standard mixture of anesthetic product 10 mg of hyperbaric bupivacaine 05 08 mg if parturients size 160 cm with 25 µg of sufentanil and morphine 01 mg is injected After intrathecal injection parturients take quickly their initial position and the first prophylactic bolus of the vasopressor 2 ml from syringe A or syringe B is administerated Oxygen is administred by ventimask at rate of 3 lmin till the delivery of the baby The level of sensory block is evaluated by pin prick test Successful sensory block is defined as block reaching T4 dermatomal level If after 20 minutes the sensory block level remains T10 a conversion to general anesthesia is performed and the patient is excluded from the study
Heart rate systolic diastolic and mean blood pressure are recorded every minute for the first 15 minutes after spinal anesthesia and every five minutes until the end of the intervention
Management of hypotension When systolic blood pressure SBP decreases to 20 of baseline a rescue bolus of vasopressor 2 ml of syringe A or syringe B is given Reinjection of the same bolus is repeated after 1 minute if hypotension persists Administration of boluses is stopped when the value of the SBP finds 80 of the baseline
After clamping of the umbilical cord Oxytocin is given as an initial bolus of 10 UI over 3 minutes followed by slow infusion of 15 UI in 09 normal saline Neonatal APGAR score at 1 minute and five minutes is recorded
Primary outcome Number of vasopressor boluses used in each group to treat hypotension SBP decreases to 20 of baseline is recorded
Secondary outcomes Complication during the surgery as incidence of hypertension SBP 20 of baseline tachycardia Heart rate HR 120 beatsmin bradycardia HR 60 beatsmin nausea and vomiting are recorded Well also recorded neonatal APGAR score of the first and 5th minute
Statistical study
Data entry and analysis will be performed by SPSS version 250 software We will use Excel 2019 software to edit the charts Descriptive study Continuous quantitative variables following a normal distribution will be expressed by their means and standard deviation Continuous quantitative variables not following a normal law will be expressed by their median and interquartile 25-75 Qualitative variables will be expressed as simple frequencies n and relative frequencies as a percentage Analytical study For the analysis of the association between two qualitative variables we will use the Pearson chi-2 test for the comparison of two frequencies under verified application conditions and the Fischer test otherwise For the analysis of the association between a qualitative variable and a quantitative variable we ll use the T test of Student for the comparison of two means and the non-parametric test of Mann Whitney otherwise We ll retain a significance threshold for p 5 In the multivariate study risk will be calculated by the Odds Ratio OR with a retained confidence interval of 95 95 CI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None