Comparative 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

• Status: Not yet recruiting
• Trial end date: 2024-05-15
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: KIST Medical and Teaching Hospital
• Treatments: Mephentermine; Oxymetazoline; Phenylephrine

Criteria

Inclusion Criteria:

1. Patient undergoing elective cesarean section under spinal anesthesia 2 .Age between 18-48 years 3. ASA class II ( all pregnant are categorized as ASA II)

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Exclusion Criteria:

1. Patient refusal

2. Contraindication to spinal anesthesia like coagulation disorder , localized infection , sepsis, raised intracranial pressure etc

3. Patchy spinal block , failed spinal block converting to GA

4. Hypersensitivity to any drugs

5. High Risk Pregnancy ( preeclampsia, eclampsia, preterm, Gestational Diabetes , etc ) -