Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During 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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-23

Study Completion Date

2021-05-31

Brief Summary

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This will be a double-blind randomized study, aiming at investigating a fixed rate phenylephrine infusion versus a fixed rate norepinephrine infusion versus placebo in combination with co-hydration with colloids for the prevention of maternal hypotension in elective cesarean section

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Detailed Description

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Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally.

The aim of the current randomized controlled double-blinded trial was to compare the effect of a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion versus placebo in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia. All parturients will also receive colloid co-hydration.

Conditions

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Hypotension Symptomatic Vasoconstriction Cesarean Section Complications Obstetric Anesthesia Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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phenylephrine infusion

fixed-rate phenylephrine infusion

Group Type ACTIVE_COMPARATOR

phenylephrine infusion

Intervention Type OTHER

in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated

norepinephrine infusion

fixed-rate norepinephrine infusion

Group Type ACTIVE_COMPARATOR

norepinephrine infusion

Intervention Type OTHER

in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated

placebo infusion

normal saline infusion

Group Type PLACEBO_COMPARATOR

placebo infusion

Intervention Type OTHER

in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated

Interventions

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phenylephrine infusion

in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated

Intervention Type OTHER

norepinephrine infusion

in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated

Intervention Type OTHER

placebo infusion

in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated

Intervention Type OTHER

Other Intervention Names

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medication used for blood pressure maintenance medication used for blood pressure maintenance medication used for blood pressure maintenance

Eligibility Criteria

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Inclusion Criteria

* adult parturients, American Society of Anesthesiologists (ASA) I-II,
* singleton gestation\>37 weeks
* elective cesarean section

Exclusion Criteria

* Body Mass Index (BMI) \>40 kg/m2
* Body weight \<50 kg
* Body weight\>100 kg
* height\<150 cm
* height\>180 cm
* multiple gestation
* fetal abnormality
* fetal distress
* active labor
* cardiac disease
* pregnancy-induced hypertension
* thrombocytopenia
* coagulation abnormalities
* use of antihypertensive medication during pregnancy
* communication or language barriers
* lack of informed consent
* contraindication for regional anesthesia

Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No