Clinical trial NCT04272567: Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension
Official title: Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effect
Keywords: Norepinephrine
Hypotension
Cesarean section
Dose-finding
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of post-spinal anesthesia hypotension
timeFrame: 1-15 minutes after spinal anesthesia.
Secondary outcomes:
measure: Overall stability of systolic blood pressure control versus baseline
timeFrame: 1-15 minutes after spinal anesthesia.
measure: Overall stability of heart rate control versus baseline
timeFrame: 1-15 minutes after spinal anesthesia.
measure: The incidence of severe post-spinal anesthesia hypotension.
timeFrame: 1-15 minutes after spinal anesthesia.
measure: The incidence of nausea and vomiting.
timeFrame: 1-15 minutes after spinal anesthesia.
measure: The incidence of bradycardia.
timeFrame: 1-15 minutes after spinal anesthesia.
measure: The incidence of hypertension.
timeFrame: 1-15 minutes after spinal anesthesia.
measure: pH
timeFrame: Immediately after delivery.
measure: Partial pressure of oxygen
timeFrame: Immediately after delivery.
measure: Base excess
timeFrame: Immediately after delivery.
measure: APGAR score
timeFrame: 1min after delivery
measure: APGAR score
timeFrame: 5min after delivery
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Xinli Ni, Dr.
role: STUDY_CHAIR
References: