Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension.

NCT ID: NCT06508359

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-02-28

Brief Summary

This study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section.

Detailed Description

Spinal anesthesia-induced hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of spinal anesthesia-induced 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 spinal anesthesia-induced hypotension. The prophylactic vasopressor strategy is more effective in enhancing hemodynamic stability and reducing adverse events such as nausea and vomiting during cesarean section, compared to rescue strategy. However, it does not demonstrate significant advantages in neonatal outcomes such as umbilical artery pH and Apgar score. The impact of various vasopressor application patterns on neonatal outcomes after cesarean section lacks further supporting evidence. Therefore, this study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section through a multicenter, single-blind, 2*2 crossover and cluster randomized trial.

Conditions

Outcome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Prophylactic norepinephrine group

A maintenance dose of norepinephrine (0.05 ug/kg/min) infusion simultaneous with spinal anesthesia. 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: EXPERIMENTAL

Norepinephrine

Intervention Type: DRUG

Prophylactic or rescue norepinephrine for spinal anesthesia-induced hypotension

Prophylactic phenylephrine group

A maintenance dose of phenylephrine (0.625 ug/kg/min) infusion simultaneous with spinal anesthesia. 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: EXPERIMENTAL

Phenylephrine

Intervention Type: DRUG

Prophylactic or rescue phenylephrine for spinal anesthesia-induced hypotension

Rescue norepinephrine 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. Spinal anesthesia-induced hypotension is managed by administering a 6 μg intravenous bolus of norepinephrine.

Group Type: ACTIVE_COMPARATOR

Norepinephrine

Intervention Type: DRUG

Prophylactic or rescue norepinephrine for spinal anesthesia-induced hypotension

Rescue phenylephrine 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. Spinal anesthesia-induced hypotension is managed by administering a 75 μg intravenous bolus of phenylephrine.

Group Type: ACTIVE_COMPARATOR

Phenylephrine

Intervention Type: DRUG

Prophylactic or rescue phenylephrine for spinal anesthesia-induced hypotension

Interventions

Norepinephrine

Prophylactic or rescue norepinephrine for spinal anesthesia-induced hypotension

Intervention Type: DRUG

Phenylephrine

Prophylactic or rescue phenylephrine for spinal anesthesia-induced hypotension

Intervention Type: DRUG

Other Intervention Names

Vasopressor; Vasopressor

Eligibility Criteria

Inclusion Criteria

• 18-45 years
• Primipara or multipara
• Singleton pregnancy ≥37 weeks
• American Society of Anesthesiologists physical status classification II
• Scheduled for cesarean section under spinal anesthesia

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 ≥140 mmHg
• 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

General Hospital of Ningxia Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi Chen, M.D.

Role: STUDY_CHAIR

General Hospital of Ningxia Medical University

Central Contacts

Yi Chen, M.D.

Role: CONTACT

czzyxgp@163.com

86-951-674-3252

Other Identifiers

Yi Chen-2025-1

Identifier Type: -

Identifier Source: org_study_id