Preload Optimization Guided by Inferior Vena Cava Collapsibility Index

• Sponsor: General Hospital of Ningxia Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04272580
• Collaborator: (none)
• Enrollment: 193
• Location: 1
• Arms: 4
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 21.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adverse Effect	Drug: Control group; Drug: 4 ml/kg group.; Drug: 8 ml/kg group.; Drug: 12 ml/kg group.	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 193 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 1, 2020
• Actual Primary Completion Date: Mar 27, 2021
• Actual Study Completion Date: Mar 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Control group No preload was given before spinal anesthesia	Drug: Control group; No preload was given before spinal anesthesia.; Other Names: Crystalloid
Experimental: 4 ml/kg group 4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia	Drug: 4 ml/kg group.; 4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.; Other Names: Crystalloid
Experimental: 8 ml/kg group 8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.	Drug: 8 ml/kg group.; 8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.; Other Names: Crystalloid
Experimental: 12 ml/kg group 12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.	Drug: 12 ml/kg group.; 12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.; Other Names: Crystalloid

Outcome Measures

Primary Outcome Measures

1. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC) [Baseline (before preload)]

   IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

2. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC) [Before spinal anesthesia (after preload)]

   IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

3. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC) [5 min after spinal anesthesia]

   IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

4. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC) [5 min after fetal delivery]

   IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

5. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC) [Before leaving the operating room]

   IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

Secondary Outcome Measures

1. The incidence of post-spinal anesthesia hypotension. [1-15 minutes after spinal anesthesia]

   Systolic blood pressure (SBP) < 80% of the baseline.

2. The incidence of severe post-spinal anesthesia hypotension. [1-15 minutes after spinal anesthesia.]

   Systolic blood pressure (SBP) < 60% of the baseline

3. The incidence of nausea and vomiting. [1-15 minutes after spinal anesthesia.]

   Presence of nausea and vomiting in patients after spinal anesthesia

4. The incidence of bradycardia [1-15 minutes after spinal anesthesia]

   Heart rate < 55 beats/min.

5. The incidence of hypertension [1-15 minutes after spinal anesthesia]

   Systolic blood pressure (SBP) >120% of the baseline

6. pH [Immediately after delivery]

   From umbilical arterial blood gases

7. Partial pressure of oxygen [Immediately after delivery]

   From umbilical arterial blood gases

8. Base excess [Immediately after delivery]

   From umbilical arterial blood gases

9. APGAR score [1min after delivery]

   A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

10. APGAR score [5min after delivery]

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

11. Overall stability of systolic blood pressure control versus baseline [1-15 minutes after spinal anesthesia.]

    Evaluated by performance error (PE).

12. Overall stability of heart rate control versus baseline [1-15 minutes after spinal anesthesia.]

    Evaluated by performance error (PE).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Hospital of Ningxia Medical University	Yinchuan	Ningxia	China	750004

Sponsors and Collaborators

• General Hospital of Ningxia Medical University

Investigators

• Study Chair: Xinli Ni, Dr., General Hospital of Ningxia Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: General Hospital of Ningxia Medical University
• ClinicalTrials.gov Identifier: NCT04272580
• Other Study ID Numbers: Yi Chen-2020-2
• First Posted: Feb 17, 2020
• Last Update Posted: Jul 6, 2021
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by General Hospital of Ningxia Medical University: Preload; Inferior vena cava collapsibility index; Norepinephrine; Cesarean section; Dose-finding

Study Results

No Results Posted as of Jul 6, 2021