Different Crystalloid Coload Volumes on the 90% ED of Norepinephrine

General Hospital of Ningxia Medical University

Status: Completed

Conditions: Adverse Effect

Treatments: Drug: Crystalloid - 5 ml/kg; Drug: Crystalloid - 0 ml/kg; Drug: Crystalloid - 10 ml/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT05690334

Yi Chen-2023-2

Details and patient eligibility

About

The purpose of this study is to investigate the effect of different crystalloid coload volumes on the 90% effective dose of prophylactic norepinephrine infusions for preventing postspinal anesthesia hypotension during cesarean section.

Full 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. Coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. In addition, there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. The purpose of this study is to investigate the effect of different crystalloid coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for cesarean section.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Control group

Experimental group

Description:

No fluid coload was given. An initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia

Treatment:

Drug: Crystalloid - 0 ml/kg

Crystalloid - 5 ml/kg

Experimental group

Description:

5 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.

Treatment:

Drug: Crystalloid - 5 ml/kg

Crystalloid - 10 ml/kg

Experimental group

Description:

10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.

Treatment:

Drug: Crystalloid - 10 ml/kg