Norepinephrine for Hypotension in Cesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-10

Study Completion Date

2022-05-04

Brief Summary

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Hypotension is a very common consequence of the sympathetic vasomotor block caused by spinal anesthesia for cesarean section. Maternal symptoms such as nausea, vomiting and dyspnea frequently accompany severe hypotension, and adverse effects on the fetus, including depressed APGAR scores and umbilical acidosis, have been correlated with severity and duration of hypotension. Because hypotension is frequent, vasopressors should be used routinely and preferably prophylactically.

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Detailed Description

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Phenylephrine has a potent direct α effect, with virtually no β effects at clinical doses, however when given at higher than required doses, it may induce baroreceptor-mediated bradycardia with a consequent reduction in maternal cardiac output. Although α agonist drugs are the most appropriate agents to treat or prevent hypotension following spinal anaesthesia, those with a small amount of β agonist activity may have the best profile (noradrenaline (norepinephrine) and metaraminol. Phenylephrine is currently recommended due to the amount of supporting data.Noradrenaline is the primary catecholamine released by postganglionic adrenergic nerves. It is a potent α adrenergic agonist, with comparatively modest β agonist activity.

Conditions

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Hypotension Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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NEP group

Norepinephrine infusion of 0.025 µg/kg/min and 6 µg bolus will be used if BP is reduced 20 % below baseline.

Group Type ACTIVE_COMPARATOR

Norepinephrine

Intervention Type DRUG

prophylaxis for hypotension

PHE group

Phenylephrine will be started at 25µg/min immediately after the intrathecal local anaesthetic injection and titrated according to blood pressure and pulse rate.

Group Type PLACEBO_COMPARATOR

Phenylephrine

Intervention Type DRUG

standerd prophylaxis for hypotension

Interventions

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Norepinephrine

prophylaxis for hypotension

Intervention Type DRUG

Phenylephrine

standerd prophylaxis for hypotension

Intervention Type DRUG

Other Intervention Names

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noradrenaline phenylephrine hydrochloride

Eligibility Criteria

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Inclusion Criteria

* Patients who fall in category 2 and 3 according to the classification of Caesarean section made by Royal College of Obstetrician and Gynaecologists.

Exclusion Criteria

* Patient refusal either to study enrollment or to spinal anesthesia.

* Any absolute contraindication to spinal anesthesia e.g. coagulopathy, skin infection at site of injection.
* Allergy to any of study drugs.
* Patients with cardiac morbidities, hypertensive disorders or peripartum bleeding
* BMI \> 40 kg/m²
* Baseline systolic blood pressure \< 100 mmHg.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No