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

NCT06151470 | Unknown

• 1 other identifier: Yi Chen-2024-8
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Adverse Effect

Outcome Measures

Primary Outcomes (1)

• ED50 and ED90

  The dose of prophylactic phenylephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients

  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

OTHER

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

OTHER

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

An initial infusion dose of prophylactic phenylephrine (0.625 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.125 ug/kg/min of prophylactic phenylephrine according to the responses of previous patients according to the up-down sequential allocation.

Also known as: Phenylephrine

Standard group

α-adrenergic receptor agonist DRUG

An initial infusion dose of prophylactic phenylephrine (0.625 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.125 ug/kg/min of prophylactic phenylephrine according to the responses of previous patients according to the up-down sequential allocation.

Also known as: Phenylephrine

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 ≥32 weeks
• American Society of Anesthesiologists physical status classification I to III
• Scheduled for cesarean section under spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

MeSH Terms

Interventions

Phenylephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Yi Chen, M.D.

  General Hospital of Ningxia Medical University

  STUDY CHAIR

Central Study Contacts

Yi Chen, M.D.

CONTACT

86-951-674-3252; czzyxgp@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• 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: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 30, 2023

Record last verified: 2023-11