Comparative Analytical Study of Intravenous Bolus Dose of Mephentermine and Phenylephrine for Hemodynamic Stability During Elective Cesarean Section Under Spinal Anesthesia at KIST Medical College and Teaching Hospital

Study Overview
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Brief Summary
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Hemodynamics changes with spinal anesthesia is mainly due to sympathetic block which causes mainly hypotension & bradycardia. Post spinal hypotension usually leads to various adverse maternal and fetal outcomes. Hence, effective prevention and treatment of maternal hypotension is of great clinical significance. Various studies have been done for the prevention of subarachnoid block induced hypotension but the optimal choice of vasopressors for the maintenance of hemodynamic stability during cesarean under spinal anesthesia is still unclear. The ideal vasopressor would be the one which is reliable and easy to use , has rapid onset, short duration of action, easily tritatable, can potentially be used prophylactically and lack any adverse maternal and fetal impact. Thus, aim of study is to compare the hemodynamic stability of mephenterime and phenylephrine during elective cesarean section under spinal anesthesia. The methodology of the study will be prospective, randomized double blinded study where patient meeting inclusion criteria for the study is divided into two groups ( Group M n=21) and ( Group P n= 21) i.e. Group M receives intravenous bolus of mephentermine 6mg and intravenous bolus of 50mcg. Hemodynamics changes in blood pressure and heart rate will monitored and compared among the study groups receiving intravenous boluses of study drugs. Data will be collected in proforma and saved by entering in the MS- EXCEL as well. Data will be analyzed using the statistical package for the social sciences (SPSS) version 27. The categorical data will be analyzed with Chi-square test and numerical variables of hemodynamic parameters between the study groups will be analyzed using student t- test. P-value < 0.05 will be considered statistically significant. Hence, mephenterime and phenylephrine effectiveness will be studied for hemodynamic stability during cesarean section under spinal anesthesia

Detailed Description
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Spinal anesthesia is the most common administered neuraxial anesthetic technique for patient undergoing cesarean section due to its rapid and reliable onset and remains preferred choice for cesarean deliveries. The advantage of spinal anesthesia includes no airway manipulation, profound analgesia and anesthesia, minimal maternal and fetal drug exposure stable hemodynamic parameters (based on level of anesthesia), decrease intraoperative blood loss and provide postoperative pain control. Hemodynamics changes is due to sympathetic block which causes reduction in venous return which further reduces the cardiac output and blood pressure by activation of Bezold Jarisch reflex In addition, the vasodilatory effect due to prostaglandins, progesterone relaxin and nitric oxide during pregnancy and loss of intrinsic sympathetic vascular tone further exaggerated fall of blood pressure with prevalence of 50-90% despite of fluid preload and uterine displacement Various preventive measures like fluid preload , left lateral tilt , left uterine displacement and along with vasopressors such as mephentermine , phenylephrine have been tried to prevent hypotension Phenylephrine is currently recommended as 1st line of vasopressor which acts as alpha 1 agonist with negligible beta action increasing blood pressure due to vasoconstriction whereas it causes dose dependent bradycardia and decrease cardiac output Mephentermine non catecholamine nondirectly acts on both adrenergic alpha and beta receptors and indirectly by releasing norepinephrine and epinephrine that increases blood pressure and augments cardiac output whereas tachyphylaxis may occur rapidly. This study would help to compare the effectiveness of phenylephrine and mephentermine for maintenance of hemodynamic parameters in patient undergoing cesarean section under spinal anesthesia.

Official Title
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Comparative Analytical Study of Intravenous Bolus Dose of Mephentermine and Phenylephrine for Hemodynamic Stability During Elective Cesarean Section Under Spinal Anesthesia at KIST Medical College and Teaching Hospital

Conditions
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Hemodynamic Stability

Intervention / Treatment
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* Drug: Intravenous bolus dose of Mephentermine and mephentermine
* Drug: intravenous bolus dose of phenylephrine 50 mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient undergoing elective cesarean section under spinal anesthesia Age between 18-48 years ASA class II ( all pregnant are categorized as ASA II) Exclusion Criteria: Patient refusal Contraindication to spinal anesthesia like coagulation disorder , localized infection , sepsis, raised intracranial pressure etc Patchy spinal block , failed spinal block converting to GA Hypersensitivity to any drugs High Risk Pregnancy ( preeclampsia, eclampsia, preterm, Gestational Diabetes , etc )

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparative Interventional
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mephentermine ( M group)<br>Group M | Drug: Intravenous bolus dose of Mephentermine and mephentermine<br>* intravenous bolus dose of mephenteramine 6mg<br>* Other names: Mephentermine;|
| Experimental: Phenylephrine ( P group )<br>Group P | Drug: intravenous bolus dose of phenylephrine 50 mcg<br>* intravenous bolus dose of phenylephrine 50 mcg<br>* Other names: Phenylephrine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the intravenous bolus dose of mephentermine and phenylephrine for hemodynamic stability during elective cesarean section under spinal anesthesia | To measure systolic blood pressure ( SBP) and diastolic blood pressure ( DBP) of the study groups | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure Mean Arterial Pressure ( MAP ) of study groups | Mean Arterial Pressure will be measured and compared between study groups | 6 months | 
| To measure heart rate ( HR) of study group | Heart rate will be measured and compared between study groups | 6 months |