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

NCT06668337 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-10-31

No results posted yet for this study

Summary

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.

Conditions

  • Hypotension After Spinal Anesthesia
  • Hypotension During Cesarean Delivery

Interventions

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.

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.

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.

Sponsors & Collaborators

  • B.P. Koirala Institute of Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-08-01
Completion
2022-02-15

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06668337 on ClinicalTrials.gov