This is a Study That Aims to Estimate the Effect of Maternal Body Mass Index on the Prophylactic Dose of Norepinephrine Infusion for Preventing Hypotension in Parturient After Spinal Anesthesia

NCT07706426 | Not Yet Recruiting

• 1 other identifier: FMASU MD 46/2026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blinded controlled study that aims to estimate the effect of maternal body mass index on the prophylactic dose of norepinephrine infusion for preventing hypotension in parturient after spinal anesthesia.

Conditions

Post Spinal Anaesthesia Hypotension

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension after spinal anesthesia

  Hypotension defined as a ≥20% decrease in systolic blood pressure from baseline.

  From spinal anesthesia until delivery of the fetus.

Secondary Outcomes (6)

• Reactive hypertension

  From spinal anesthesia until the end of surgery.

• Bradycardia

  From spinal anesthesia until the end of surgery.

• Nausea and vomiting

  From spinal anesthesia until the end of surgery.

• Apgar score at 1 minute

  1 minute after delivery.

• Apgar score at 5 minutes

  5 minutes after delivery.

Study Arms (10)

Non_obese + NE 0 mic/kg/min

PLACEBO COMPARATOR

Non\_obese Patients BMI \<30 kg/m2 receiving placebo (normal saline )infusion after spinal anesthesia.

Drug: Normal Saline

Non_obese + NE 0.025mic/kg/min

ACTIVE COMPARATOR

Non\_obese Patients BMI \<30 kg/m2 receiving prophylactic nor epinephrine infusion at 0.025mic/kg/min after spinal anesthesia.

Drug: Nor-epinephrine

Non_obese + NE 0.05mic/kg/min

ACTIVE COMPARATOR

Non\_obese Patients BMI \<30 kg/m2 receiving prophylactic nor epinephrine infusion at 0.05mic/kg/min after spinal anesthesia.

Drug: Nor-epinephrine

Non_obese + NE 0.075mic/kg/min

ACTIVE COMPARATOR

Non\_obese Patients BMI \<30 kg/m2 receiving prophylactic nor epinephrine infusion at 0.075mic/kg/min after spinal anesthesia.

Drug: Nor-epinephrine

Non_obese + NE 0.1mic/kg/min

ACTIVE COMPARATOR

Non\_obese Patients BMI \<30 kg/m2 receiving prophylactic nor epinephrine infusion at 0.1mic/kg/min after spinal anesthesia.

Drug: Nor-epinephrine

Obese + NE 0 mic/kg/min

PLACEBO COMPARATOR

Obese Patients BMI \>30 kg/m2 receiving placebo (normal saline )infusion after spinal anesthesia.

Drug: Normal Saline

Obese + NE 0.025 mic/kg/min

ACTIVE COMPARATOR

Obese Patients BMI\>30 kg/m2 receiving prophylactic nor epinephrine infusion at 0.025 mic/kg/min after spinal anesthesia.

Drug: Nor-epinephrine

Obese + NE 0.05 mic/kg/min

ACTIVE COMPARATOR

Obese Patients BMI\>30 kg/m2 receiving prophylactic nor epinephrine infusion at 0.05 mic/kg/min after spinal anesthesia.

Drug: Nor-epinephrine

Obese + NE 0.075 mic/kg/min

ACTIVE COMPARATOR

Obese Patients BMI\>30 kg/m2 receiving prophylactic nor epinephrine infusion at 0.075 mic/kg/min after spinal anesthesia.

Drug: Nor-epinephrine

Obese + NE 0.1 mic/kg/min

ACTIVE COMPARATOR

Obese Patients BMI\>30 kg/m2 receiving prophylactic nor epinephrine infusion at 0.1 mic/kg/min after spinal anesthesia.

Drug: Nor-epinephrine

Interventions

Nor-epinephrine DRUG

norepinephrine infusion doses ( 0.025, 0.05, and 0.075, 0.1 mic/kg/min) post spinal anesthesia .

Non_obese + NE 0.025mic/kg/min; Non_obese + NE 0.05mic/kg/min; Non_obese + NE 0.075mic/kg/min; Non_obese + NE 0.1mic/kg/min; Obese + NE 0.025 mic/kg/min; Obese + NE 0.05 mic/kg/min; Obese + NE 0.075 mic/kg/min; Obese + NE 0.1 mic/kg/min

Normal Saline DRUG

normal saline infusion post spinal anesthesia .

Non_obese + NE 0 mic/kg/min; Obese + NE 0 mic/kg/min

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: pregnant women scheduled for elective C/S under spinal anesthesia
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A normal singleton pregnancy with a gestational age of ≥ 37 weeks. 18-40 years old pregnant women scheduled for elective C/S under spinal anesthesia.

You may not qualify if:

• Any absolute contraindication to spinal block, Neurological or cardiac disorder, Basal systolic blood pressure above 140 mmHg or below 100 mmHg, Peripartum bleeding or emergent situations both for fetus and mother, Those who refused to participate in the study were excluded Known fetal abnormality, intrauterine growth restriction, Obstetric complication (ruptured membranes, placenta previa, placental abruption),

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams

Cairo, Abbasia, 00202, Egypt

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Merna M.k. Mohy, M.SC

CONTACT

+201065606283; mernakamal77@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 15, 2026
• Study Start: July 9, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

EG (1)