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Effect of Three Weight-adjusted Vasopressors for Elective Cesarean Delivery

NCT ID: NCT04991662

Last Updated: 2021-12-30

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

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-10

Study Completion Date

2021-12-03

Brief Summary

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This study compared the effects of prophylactic infusion of metaraminol, phenylephrine and norepinephrine adjusted according to body weight on fetal acid-base balance and maternal hemodynamics.

Detailed Description

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At present, the ED90 of metaraminol, phenylephrine, and norepinephrine in the prevention of cesarean section hypotension has been explored. We compare the effects of three drugs on the fetus and mothers at the concentration of ED90 to provide advice on the use of vasoactive drugs for obstetrics anesthesia .

Conditions

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Cesarean Section Complications

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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metaraminol group

During the cesarean section, metaraminol 2ug/kg/min is preventively infused after anesthesia to prevent and treat hypotension.

Group Type EXPERIMENTAL

metaraminol

Intervention Type DRUG

Infusion of metaraminol adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

phenylephrine group

During cesarean section, preventive infusion of phenylephrine 0.54ug/kg/min after anesthesia to prevent and treat hypotension.

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

Infusion of Phenylephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

norepinephrine group

During cesarean section, preventive infusion of norepinephrine 0.08ug/kg/min after anesthesia to prevent and treat hypotension.

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

Infusion of Norepinephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

Interventions

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metaraminol

Infusion of metaraminol adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

Intervention Type DRUG

Phenylephrine

Infusion of Phenylephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

Intervention Type DRUG

Norepinephrine

Infusion of Norepinephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

Intervention Type DRUG

Other Intervention Names

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M group P group N group

Eligibility Criteria

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Inclusion Criteria

1. Singleton pregnancy at term scheduled to be delivered via elective cesarean delivery;
2. height 150-180 cm;
3. American Society of Anesthesiologists (ASA) physical status II-III;
4. body mass index (BMI) \<35 kg/m2.

Exclusion Criteria

1. transverse presentation, fetal macrosomia;
2. uterine abnormalities (eg, large fibroids, bicornuate uterus);
3. polyhydramnios;
4. ruptured membranes, oligohydramnios;
5. intrauterine growth restriction;
6. gestational or nongestational hypertension, diabetes, or eclampsia;
7. hypertensive disorders or any condition associated with autonomic neuropathy (such as diabetes mellitus for \>10 years) or renal failure;
8. contraindications for combined spinal-epidural anesthesia;
9. participants who declined to sign informed consent forms.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Xuzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chao Xu

Head of Otolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Feng Yi, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Department of Anesthesiology and Operating Room, Affiliated Hospital of Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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SFY2021-HZ08-11

Identifier Type: -

Identifier Source: org_study_id