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90% Effective Dose of Norepinephrine Infusions Under Intensive and Standard Treatment in Preeclamptic Patients

NCT ID: NCT06151457

Last Updated: 2023-11-30

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-06-30

Brief Summary

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The objective of this study is to investigate the 90% effective dose of norepinephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment in preeclamptic patients during cesarean section

Detailed Description

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Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the 90% effective dose of norepinephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment in preeclamptic patients during cesarean section.

Conditions

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Adverse Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Standard group

The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

Group Type OTHER

Alpha-Agonist

Intervention Type DRUG

An initial infusion dose of prophylactic norepinephrine (0.05 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.01 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.

Intensive group

The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

Group Type OTHER

α-adrenergic receptor agonist

Intervention Type DRUG

An initial infusion dose of prophylactic norepinephrine (0.05 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.01 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.

Interventions

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Alpha-Agonist

An initial infusion dose of prophylactic norepinephrine (0.05 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.01 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.

Intervention Type DRUG

α-adrenergic receptor agonist

An initial infusion dose of prophylactic norepinephrine (0.05 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.01 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.

Intervention Type DRUG

Other Intervention Names

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Norepinephrine Norepinephrine

Eligibility Criteria

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Inclusion Criteria

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥32 weeks
* American Society of Anesthesiologists physical status classification I to III
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria

* Baseline blood pressure ≥160 mmHg
* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi Chen, M.D.

Role: STUDY_CHAIR

General Hospital of Ningxia Medical University

Central Contacts

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Yi Chen, M.D.

Role: CONTACT

Phone: 86-951-674-3252

Email: [email protected]

Other Identifiers

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Yi Chen-2024-7

Identifier Type: -

Identifier Source: org_study_id