Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Maternal Hemodynamics

NCT06151496 | Unknown

• 1 other identifier: Yi Chen-2024-2
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics following cesarean section.

Conditions

Outcome

Outcome Measures

Primary Outcomes (4)

• Cardiac output

  Monitoring data

  1-15 minutes after spinal anesthesia.

• Cardiac index

  Monitoring data

  1-15 minutes after spinal anesthesia.

• Stroke volume variation

  Monitoring data

  1-15 minutes after spinal anesthesia.

• Peripheral vascular resistance

  Monitoring data

  1-15 minutes after spinal anesthesia.

Secondary Outcomes (10)

• The incidence of post-spinal anesthesia hypotension

  1-15 minutes after spinal anesthesia.

• The incidence of severe post-spinal anesthesia hypotension.

  1-15 minutes after spinal anesthesia.

• The incidence of bradycardia.

  1-15 minutes after spinal anesthesia.

• The incidence of nausea and vomiting.

  1-15 minutes after spinal anesthesia.

• The incidence of hypertension.

  1-15 minutes after spinal anesthesia.

Study Arms (2)

Standard group

ACTIVE COMPARATOR

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

Drug: Alpha-Agonist

Intensive group

EXPERIMENTAL

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

Drug: α-adrenergic receptor agonist

Interventions

Alpha-Agonist DRUG

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

Also known as: Vasopressors

Standard group

α-adrenergic receptor agonist DRUG

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

Also known as: Vasopressors

Intensive group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years
• Primipara or multipara
• Singleton pregnancy ≥37 weeks
• American Society of Anesthesiologists physical status classification I to II
• Scheduled for cesarean section under spinal anesthesia

You may not qualify if:

• Body height \< 150 cm
• Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
• Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
• Hemoglobin \< 7g/dl
• Fetal distress, or known fetal developmental anomaly

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

MeSH Terms

Interventions

Vasoconstrictor Agents

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Xinli Ni, Ph.D

  General Hospital of Ningxia Medical University

  STUDY CHAIR

Central Study Contacts

Yi Chen, M.D.

CONTACT

+86-0951-6743252; czzyxgp@163.com

Xinli Ni, Ph.D

CONTACT

+86-0951-6743252; xinlini6@nyfy.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 30, 2023

Record last verified: 2023-11