Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension

General Hospital of Ningxia Medical University

Status: Completed

Conditions: Adverse Effect

Treatments: Drug: Normal saline; Drug: Norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04272567

Yi Chen-2020-1

Details and patient eligibility

About

The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.

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. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.

Enrollment: 99 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-40 years
• Primipara or multipara
• Singleton pregnancy ≥37 weeks
• American Society of Anesthesiologists physical status classification I to II
• Scheduled for elective 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 ≥ 160mmHg
• Hemoglobin < 7g/dl
• Fetal distress, or known fetal developmental anomaly

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 5 patient groups

Control group

Sham Comparator group

Description:

Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion

Treatment:

Drug: Normal saline

0.025 μg/kg/min group

Experimental group

Description:

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.025 μg/kg/min).

Treatment:

Drug: Norepinephrine

0.05 μg/kg/min group

Experimental group

Description:

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.05 μg/kg/min).

Treatment:

Drug: Norepinephrine

0.075 μg/kg/min group

Experimental group

Description:

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.075 μg/kg/min).

Treatment:

Drug: Norepinephrine

0.1 μg/kg/min group

Experimental group

Description:

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.1 μg/kg/min).

Treatment:

Drug: Norepinephrine