Clinical trial NCT04272580: Preload Optimization Guided by Inferior Vena Cava Collapsibility Index
Official title: Preload Optimization Guided by Inferior Vena Cava Collapsibility Index in Parturients With Prophylactic Norepinephrine Infusion Undergoing Cesarean Section: a Randomized, Dose-finding Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effect
Keywords: Preload
Inferior vena cava collapsibility index
Norepinephrine
Cesarean section
Dose-finding
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 193
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the optimal preload guided by inferior vena cava collapsibility index in parturients with prophylactic norepinephrine infusion undergoing 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. 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. However, the investigator's study (NCT03997500) had been shown that inferior vena cava collapsibility index (IVC-CI) markedly decreased in prophylactic norepinephrine infusion versus normal saline after spinal anesthesia and fetal delivery, suggesting that more prudent fluid management is required. The ideal dose of preload and coload is still unknown. Thus, the purpose of this study is to investigate the optimal preload guided by IVC-CI in parturients with prophylactic norepinephrine infusion undergoing cesarean section.

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 minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)
timeFrame: Baseline (before preload)
measure: The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)
timeFrame: Before spinal anesthesia (after preload)
measure: The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)
timeFrame: 5 min after spinal anesthesia
measure: The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)
timeFrame: 5 min after fetal delivery
measure: The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)
timeFrame: Before leaving the operating room
Secondary outcomes:
measure: The incidence of post-spinal anesthesia hypotension.
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
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.
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: