Management of Postspinal Anesthesia Hypotension During Elective Cesarean Section: Baby Norepinephrine Versus Ephedrine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Hopital Charles Nicolle
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- number of boluses of vasopressor during surgery
Study Overview
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 25.0. 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: We'll use the Pearson chi2 test or Fischer's 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
A total of 126 parturienst are randomly divided into two equal groups by an investigator not directly linked to the study.
Groupe 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. Groupe E : parturients will received ephedrine boluses (6 mg) ; systematic bolus after the induction of spinal anesthesia and therapeutic boluses if hypotention.
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.
Eligibility Criteria
- Ages
- 18 Years to 38 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Singleton full-term consenting pregnant females of ASA grade II, aged 18-38 years, scheduled for elective cesarean section under spinal anesthesia
Exclusion Criteria
- •Any parturient falling in the category ASA grade III and IV, contrindications to spinal anesthesia, preeclampsia, chronic hypertension, comorbidity with diabetes mellitus, cardiovascular disorders and psychiatric illness are non included.
- •They are excluded the case of failure of spinal anesthesia, conversion to general anesthesia, post-partum bleeding, and failure to follow protocol.
Arms & Interventions
Group E: ephedrine
Group E : parturients will received ephedrine boluses (6 mg) ; systematic bolus after the induction of spinal anesthesia and therapeutic boluses if hypotention (systolic blood pressure falls to ≤ 20% of baseline).
Intervention: Ephedrine (Drug)
Group N: norepinephrine
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
Intervention: Norepinephrine (Drug)
Outcomes
Primary Outcomes
number of boluses of vasopressor during surgery
Time Frame: number of boluses in the first hour after spinal anesthesia
number of boluses of norepinephrine in Group N and number of boluses of ephedrine in Group E, to maintain systolic blood pressure more than 80% of the baseline
Secondary Outcomes
- Incidence of hypertension(number of hypertension in the first hour after spinal anesthesia)
- Incidence of tachycardia(number of tachycardia in the first hour after spinal anesthesia)
- Incidence of bradycardia(number of bradycardia in the first hour after spinal anesthesia)
- Incidence of nausea and vomiting(the first hour after spinal anesthesia)
- Neonatal APGAR score(the first hour)
Investigators
jebri alia
Head of anesthesia and intensive care departement
Hopital Charles Nicolle