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

October 7, 2024 updated by: Dr. Raju Bikram Basnet, KIST Medical and Teaching Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
      • Lalitpur, Nepal, 56900
        • KIST Medical and Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mephentermine ( M group)
Group M
Drug: Intravenous bolus dose of Mephentermine and mephentermine
intravenous bolus dose of mephenteramine 6mg
Other Names:
  • Mephentermine
Experimental: Phenylephrine ( P group )
Group P
Drug: intravenous bolus dose of phenylephrine 50 mcg
intravenous bolus dose of phenylephrine 50 mcg
Other Names:
  • Phenylephrine

What is the study measuring?

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
Time Frame: 6 months
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
Time Frame: 6 months
Mean Arterial Pressure will be measured and compared between study groups
6 months
To measure heart rate ( HR) of study group
Time Frame: 6 months
Heart rate will be measured and compared between study groups
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KIST Medical and Teaching Hospital

Collaborators

Nepal Health Research Council

Investigators

  • Principal Investigator: Dr. Smriti Koirala, MD, KIST Medical College and Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2023

Primary Completion (Actual)

April 29, 2024

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

January 31, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KISTMTH 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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