ED90 of Norepinephrine and Phenylephrine Infusions Under Intensive Treatment

Not Applicable

Not yet recruiting

• Conditions: Adverse Effect
• Interventions: Drug: Norepinephrine; Drug: Phenylephrine

• Registration Number: NCT06158048
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief Summary

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

Detailed Description

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 ED90 of norepinephrine and phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive treatment during cesarean section

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-25
• Study First Submitted QC: 2023-11-28
• Last Update Submitted: 2023-11-28
• Study First Posted: 2023-12-06
• Last Update Posted: 2023-12-06
• Study Start: 2025-01-01
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• 18-45 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
ED50 and ED90	1-15 minutes after spinal anesthesia	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

Secondary Outcome Measures

Name	Time	Method
The incidence of post-spinal anesthesia hypotension	1-15 minutes after spinal anesthesia	Systolic blood pressure (SBP) \< 80% of the baseline