Norepinephrine Infusion vs Bolus vs Ephedrine for Blood Pressure Stability During Cesarean Delivery in Women With Preeclampsia

NCT07842783 | Completed

• 1 other identifier: Ms.11.7.2025
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will compare norepinephrine infusion, norepinephrine bolus, and ephedrine bolus for maintaining hemodynamic stability during spinal anesthesia for scheduled cesarean delivery in women with preeclampsia. Eighty-four eligible women will be randomly allocated in a 1:1:1 ratio to one of three treatment groups. The primary outcome is hemodynamic control during the first 20 minutes after spinal anesthesia, including the occurrence of hypotension, need for rescue vasopressors, and maintenance of blood pressure within ±20% of baseline. Secondary outcomes include severe hypotension, time to first hypotensive episode, vasopressor requirements, maternal adverse effects, fluid balance, and neonatal outcomes including Apgar scores, umbilical cord blood gases, and NICU admission.

Conditions

Cesarean Birth; Hypotension During Surgery; Preeclampsia

Keywords

Spinal anesthesia; Norepinephrine; Ephedrine; cesarean section; hypotension

Outcome Measures

Primary Outcomes (1)

• Incidence of Hypotension During the First 20 Minutes After Spinal Anesthesia

  The number and proportion of participants experiencing at least one episode of hypotension during the first 20 minutes after spinal anesthesia. Hypotension is defined in the study protocol as systolic blood pressure below 80% of the participant's baseline value.

  From spinal anesthesia administration through 20 minutes after spinal anesthesia

Secondary Outcomes (3)

• the incidence of severe hypotension

  From spinal anesthesia administration and through the surgery

• Need for Additional Rescue Vasopressors

  During the First 20 Minutes After Spinal Anesthesia

• time to first hypotensive episode

  after spinal anesthesia and throughout the surgery

Study Arms (3)

Norepinephrine Infusion

EXPERIMENTAL

Participants will receive a prophylactic intravenous norepinephrine infusion at 0.05 µg/kg/min, started immediately after spinal injection and titrated by ±0.02 µg/kg/min every 2 minutes to maintain systolic blood pressure at or above 80% of baseline. If hypotension persists despite two vasopressor doses or infusion adjustments, the infusion rate may be increased by 0.02-0.05 µg/kg/min according to the study rescue protocol.

Drug: Norepinephrine (0.05 μg/kg/min)

Norepinephrine Bolus

ACTIVE COMPARATOR

Participants will receive intravenous norepinephrine 4 µg as a bolus when systolic blood pressure falls below 80% of baseline, repeated every 2 minutes as needed. If hypotension persists after two vasopressor doses, the norepinephrine bolus may be escalated to 6 µg according to the study rescue protocol.

Drug: Norepinephrine 4mcg

Ephedrine Bolus

ACTIVE COMPARATOR

Participants will receive intravenous ephedrine 6 mg as a bolus when systolic blood pressure falls below 80% of baseline, repeated every 3 minutes as needed. If hypotension persists after two vasopressor doses, the ephedrine bolus may be escalated to 10 mg according to the study rescue protocol.

Drug: Ephedrine Bolus 6 mg

Interventions

Norepinephrine (0.05 μg/kg/min) DRUG

Participants will receive a prophylactic intravenous norepinephrine infusion at 0.05 µg/kg/min, started immediately after spinal injection and titrated by ±0.02 µg/kg/min every 2 minutes to maintain systolic blood pressure at or above 80% of baseline. If hypotension persists despite two vasopressor doses or infusion adjustments, the infusion rate may be increased by 0.02-0.05 µg/kg/min according to the study rescue protocol.

Norepinephrine Infusion

Norepinephrine 4mcg DRUG

Participants will receive intravenous norepinephrine 4 µg as a bolus when systolic blood pressure falls below 80% of baseline, repeated every 2 minutes as needed. If hypotension persists after two vasopressor doses, the norepinephrine bolus may be escalated to 6 µg according to the study rescue protocol.

Norepinephrine Bolus

Ephedrine Bolus 6 mg DRUG

Participants will receive intravenous ephedrine 6 mg as a bolus when systolic blood pressure falls below 80% of baseline, repeated every 3 minutes as needed. If hypotension persists after two vasopressor doses, the ephedrine bolus may be escalated to 10 mg according to the study rescue protocol.

Ephedrine Bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women older than 18 years of age with preeclampsia. American Society of Anesthesiologists (ASA) physical status II-III. Preeclampsia defined by systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg on two measurements at least 4 hours apart in a previously normotensive woman, accompanied by proteinuria (≥300 mg/24 hours or equivalent) or evidence of end-organ dysfunction, such as thrombocytopenia, renal or hepatic impairment, pulmonary edema, or neurological symptoms.
• Singleton pregnancy. Gestational age ≥37 weeks. Scheduled cesarean delivery under spinal anesthesia.

You may not qualify if:

• Refusal to participate in the study. Chronic hypertension or chronic hypertension with preeclampsia. Comorbid conditions, including diabetes mellitus or cardiovascular disease. Suspected fetal compromise. Emergency cesarean section.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypotension

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to group allocation throughout the study. A nurse who is not involved in patient care will prepare the assigned vasopressor medication before administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia, Faculty of Medicine, Benha University

Model Details: This is a prospective, randomized, three-arm, parallel-group controlled trial. Participants will be randomly allocated in a 1:1:1 ratio to receive norepinephrine infusion, norepinephrine bolus, or ephedrine bolus during spinal anesthesia for scheduled cesarean delivery in women with preeclampsia. Participants remain in their assigned intervention group throughout the study, and maternal and neonatal outcomes will be compared among the three groups.

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: July 18, 2025
• Primary Completion: June 18, 2026
• Study Completion: July 18, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

EG (1)