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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

ConditionPost Spinal Anaesthesia Hypotension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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),

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nor-epinephrine

    Drug

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

  • Normal Saline

    Drug

    normal saline infusion post spinal anesthesia .

Treatment groups

80 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Non_obese + NE 0 mic/kg/minPlacebo comparator 1 intervention
Group B: Non_obese + NE 0.025mic/kg/minActive comparator 1 intervention
Group C: Non_obese + NE 0.05mic/kg/minActive comparator 1 intervention
Group D: Non_obese + NE 0.075mic/kg/minActive comparator 1 intervention
Group E: Non_obese + NE 0.1mic/kg/minActive comparator 1 intervention
Group F: Obese + NE 0 mic/kg/minPlacebo comparator 1 intervention
Group G: Obese + NE 0.025 mic/kg/minActive comparator 1 intervention
Group H: Obese + NE 0.05 mic/kg/minActive comparator 1 intervention
Group I: Obese + NE 0.075 mic/kg/minActive comparator 1 intervention
Group J: Obese + NE 0.1 mic/kg/minActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of hypotension after spinal anesthesia

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

Time frame
From spinal anesthesia until delivery of the fetus.

Secondary outcomes

1

Reactive hypertension

Incidence of systolic blood pressure ≥20% above baseline.

Time frame
From spinal anesthesia until the end of surgery.
2

Bradycardia

Heart rate \<60 beats/min.

Time frame
From spinal anesthesia until the end of surgery.
3

Nausea and vomiting

Incidence of maternal nausea and/or vomiting.

Time frame
From spinal anesthesia until the end of surgery.
4

Apgar score at 1 minute

Neonatal Apgar score.

Time frame
1 minute after delivery.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: