CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 42 enrolled
Drug / intervention
Intravenous bolus dose of Mephentermine and mephentermine +1 moredrug
Likely dose
intravenous bolus dose of phenylephrine 50 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05706727
NCT05706727Phase 3Completed

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

KIST Medical and Teaching Hospital·interventional·Posted Jan 31, 2023·Updated Oct 9, 2024

In Brief

A Phase 3 clinical trial evaluating Intravenous bolus dose of Mephentermine and mephentermine and intravenous bolus dose of phenylephrine 50 mcg for Hemodynamic Stability. Completed, enrolled 42 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNepal

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedJan 31, 2023
Enrollment StartMar 23, 2023
Primary CompletionApr 29, 2024
Study CompletionMay 15, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.4 years ago

Interventions

Intravenous bolus dose of Mephentermine and mephenterminedrug

intravenous bolus dose of mephenteramine 6mg

intravenous bolus dose of phenylephrine 50 mcgdrug

intravenous bolus dose of phenylephrine 50 mcg