Incidence of Post-spinal Hypotension
Conditions
Brief summary
We hypothesize that the addition of ephedrine to norepinephrine infusion could decrease the incidence of post spinal hypotension(PSH) in parturient undergoing C.S under spinal anesthesia and minimize the changes in heart rate
Detailed description
Aim of the work: To compare between concomitant use of norepinephrine infusion with ephedrine versus use of norepinephrine infusion alone on maternal B.P following induction of spinal anaesthesia for C.S delivery. Statistical analysis Sample Size: Our primary outcome is the incidence of post-spinal hypotension. In a previous study incidence of post spinal hypotension in the noradrenaline group was 32%. We calculated a sample size that could detect at least 50% difference between study groups. Using MedCalc Software version 14 (MedCalc Software bvba, Ostend, Belgium), a sample size of 246 patients will be needed to have a study power of 80% and alpha error of 0.05. The number was increased to be 260 envelopes (130 envelopes per group) to compensate for possible dropouts. Statistical analysis: Analysis of data will be performed using Statistical package for social science (SPSS) software, version 26 for Microsoft Windows (SPSS Inc., Chicago, iL, USA). Categorical data will be reported as frequency and percentages and will be analyzed using chi-squared test. Continuous data will be checked for normality using Kolmogorov-Smirnov test. Normally distributed data will be presented as means ±standard deviations and will be analyzed using unpaired student t-test. Skewed data will be expressed as medians(quartiles) and will be analyzed using Mann Whitney U test. A two-way repeated measures ANOVA will be used to evaluate dose (between-groups factor) and time (repeated measures)". P value of 0.05 or less will be considered significant.
Interventions
4 ml normal saline direct I.V will be given simultaneous with norepinephrine (to keep blinding) Infusion 0.08 mcg/kg/min only be infused
DRUGEphedrine and Norepinephrine infusion
Ephedrine 10 mg (2.5mg/ml) direct I.V will be given simultaneous with Norepinephrine infusion 0.08 mcg/kg/min
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status II * Age: 18 to 40 years * Undergoing Elective Lower Segment Cesarean Section under Spinal Anesthesia.
Exclusion criteria
* Uncontrolled cardiac morbidities As reduction of ejection fraction\< 60%, History (within 3months) of myocardial infarction, cerebrovascular accident, transient ischemic attacks or coronary artery disease/stents * Poorly controlled Hypertensive disorders of pregnancy * Peripartum bleeding * Coagulation disorders * Baseline systolic blood pressure (SBP) \< 100 mmHg * Refusal of patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of post-spinal hypotension | Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of bradycardia | Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus | Defined as heart rate \< 55 bpm |
| Reactive hypertension | Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus | Defined as SBP \> 120% from the baseline reading |
| Systolic blood pressure | Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus | — |
| Heart rate | Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus | — |
| Rescue vasopressor consumption | Just after spinal anaesthesia until delivery of the fetus | Cumulative intraoperative boluses of ephedrine and norepinephrine doses |
| Neonatal outcomes Apgar Score | Within 5 minutes of baby delivery | The Apgar score comprises five components: 1- color, 2- heart rate, 3- reflexes, 4- muscle tone, and 5- respiration, each of which is given a score of 0, 1, or 2 |
Countries
Egypt
Contacts
CONTACTMohamed AMY AMY Ollaek, Assistant Professor
CONTACTIslam Reda, Lecturer
PRINCIPAL_INVESTIGATORMohamed A Ollaek, MD
Faculty of Medicine, Cairo University, Cairo
Outcome results
None listed