Ephedrine Doses to Prevent Maternal Hypotension After Spinal Anesthesia in Cesarean Section

October 30, 2024 updated by: Narottam Jha, B.P. Koirala Institute of Health Sciences

A Randomized Controlled Trial Comparing the Effectiveness of Different Doses of Ephedrine Infusion in Preventing Maternal Hypotension Following Spinal Anesthesia for Caesarean Section

This randomized controlled trial aims to compare the effectiveness of different doses of ephedrine infusion in preventing maternal hypotension following spinal anesthesia in parturients undergoing cesarean sections. The study includes 120 participants, aged 18-40 years, with American Society of Anesthesiologists (ASA) physical status II, who are scheduled for elective cesarean delivery. The primary objective is to determine whether low-dose ephedrine infusions at 1.25 mg/min or 1.5 mg/min effectively reduce the incidence of maternal hypotension, with secondary outcomes assessing the need for rescue ephedrine, incidence of side effects (nausea, vomiting, tachycardia), and neonatal Apgar scores. Researchers will compare three groups-saline, 1.25 mg/min ephedrine, and 1.5 mg/min ephedrine-to evaluate their impact on maternal hemodynamic stability.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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
      • Dharan, Nepal
        • B.P. Koirala Institute of Health Sciences

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients undergoing cesarean section
  • Self-identified as female
  • American Society of Anesthesiologists (ASA) physical status II
  • Aged between 18 to 40 years
  • Full-term singleton pregnancies planned for cesarean delivery under spinal anesthesia

Exclusion Criteria:

  • Body mass index (BMI) ≥ 40 kg/m²
  • Height less than 145 cm
  • Presence of severe neurological or psychiatric conditions
  • History of pre-eclampsia
  • Severe renal or metabolic disorders
  • Contraindications to spinal anesthesia
  • Antenatal evidence of fetal anomalies
  • Cases with severely compromised fetuses requiring immediate general anesthesia
  • Baseline systolic blood pressure (SBP) less than 90 mm Hg
  • Pregnancy-induced hypertension
  • Refusal to provide written consent

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Group A who received normal saline immediately after the administration of the
Participants in this group received normal saline immediately after the administration of the subarachnoid block (spinal anesthesia). This group serves as the control group to compare the effectiveness of ephedrine against no pharmacologic intervention
Drug: Normal Saline (Placebo)
Participants in the control group receive a continuous intravenous infusion of normal saline, which serves as an inert placebo with no pharmacological effect. This intervention mimics the administration of the active treatments, allowing for direct comparison with the ephedrine groups to assess the effectiveness of the drug in preventing maternal hypotension during spinal anesthesia.
Experimental: Group B who received ephedrine at a dosage of 1.25 mg/min immediately after the subarachnoid block
Participants in this group received ephedrine at a dosage of 1.25 mg/min immediately after the subarachnoid block. This dose is intended to prevent maternal hypotension by maintaining blood pressure during spinal anesthesia.
Drug: Ephedrine
The interventions in this study include a control group receiving normal saline, which serves as an inert placebo to assess the effectiveness of the active treatments. Participants in Group B receive an ephedrine infusion at 1.25 mg/min, while those in Group C receive a higher dosage of 1.5 mg/min. This design allows for direct comparison of the two dosages of ephedrine against the control, enabling evaluation of their effectiveness in preventing maternal hypotension following spinal anesthesia during cesarean sections.
Experimental: Group C who received ephedrine at a dosage of 1.5 mg/min immediately after the subarachnoid block
Participants in this group received ephedrine at a higher dosage of 1.5 mg/min immediately following the subarachnoid block. This intervention tests whether a slightly higher dose of ephedrine provides better prevention of maternal hypotension without increasing side effects.
Drug: Ephedrine
The interventions in this study include a control group receiving normal saline, which serves as an inert placebo to assess the effectiveness of the active treatments. Participants in Group B receive an ephedrine infusion at 1.25 mg/min, while those in Group C receive a higher dosage of 1.5 mg/min. This design allows for direct comparison of the two dosages of ephedrine against the control, enabling evaluation of their effectiveness in preventing maternal hypotension following spinal anesthesia during cesarean sections.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Hypotension in Patients Undergoing Cesarean Section Following Spinal Anesthesia.
Time Frame: Hypotension episodes were monitored and recorded intraoperatively, immediately following the administration of spinal anesthesia until the end of the cesarean section procedure. The time frame for evaluating this outcome was during the surgical procedure
The primary outcome of the study is the incidence of maternal hypotension, defined as a decrease in systolic blood pressure (SBP) by more than 20% from baseline, in patients who received different doses of ephedrine (1.25 mg/min or 1.5 mg/min) or saline infusion following spinal anesthesia for cesarean section.
Hypotension episodes were monitored and recorded intraoperatively, immediately following the administration of spinal anesthesia until the end of the cesarean section procedure. The time frame for evaluating this outcome was during the surgical procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
B.P. Koirala Institute of Health Sciences

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRC/1598/019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be made available to researchers upon request. The data will be shared in a de-identified format to protect participant confidentiality.

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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