ED90 of Norepinephrine and Phenylephrine Boluses Under Intensive Treatment

NCT06158009 | Unknown

• 1 other identifier: Yi Chen-2024-10
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine boluses for treating postspinal anesthesia hypotension under intensive treatment during cesarean section

Conditions

Adverse Effect

Outcome Measures

Primary Outcomes (1)

• ED50 and ED90

  The doses of prophylactic norepinephrine and 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)

Norepinephrine 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: Norepinephrine

Phenylephrine 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: Phenylephrine

Interventions

Norepinephrine DRUG

An initial infusion dose of prophylactic norepinephrine (6 ug) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 1 ug of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.

Also known as: Vasopressor

Norepinephrine group

Phenylephrine DRUG

An initial infusion dose of prophylactic phenylephrine (75 ug) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 12.5 ug of prophylactic phenylephrine according to the responses of previous patients according to the up-down sequential allocation.

Also known as: Vasopressor

Phenylephrine 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

Norepinephrine; Vasoconstrictor Agents; Phenylephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

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 25, 2023
• First Posted: December 6, 2023
• Study Start: April 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-11