Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index

• Sponsor: General Hospital of Ningxia Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03997500
• Collaborator: (none)
• Enrollment: 195
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 16.3

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect of norepinephrine on inferior vena cava collapsibility index (IVC-CI).

Condition or Disease	Intervention/Treatment	Phase
Adverse Effect	Drug: normal saline; Drug: Norepinephrine	N/A

Detailed Description

Post-spinal hypotension is a frequent complication during spinal anesthesia for cesarean delivery. It affects nearly 50-60% of patients without appropriately treat. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal hypotension. Norepinephrine is new vasopressor that has been suggested as a potential alternative to phenylephrine and was recently introduced in obstetric anesthesia because of the minimal cardiac depressant effect. The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect on inferior vena cava collapsibility index (IVC-CI).

Study Design

• Study Type: Interventional
• Actual Enrollment: 195 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index During Cesarean Delivery: a Randomized Double Blinded Controlled Study
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Oct 21, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Normal saline Simultaneous with subarachnoid block, a bolus of normal saline was given followed by normal saline infusion	Drug: normal saline; a bolus of normal saline was given followed by normal saline infusion; Other Names: NS
Experimental: Norepinephrine Simultaneous with subarachnoid block, a bolus of norepinephrine was given followed by norepinephrine infusion	Drug: Norepinephrine; a bolus of norepinephrine was given followed by norepinephrine infusion; Other Names: Vasopressors

Outcome Measures

Primary Outcome Measures

1. The incidence of hypotension [1 to 20 minutes after subarachnoid block]

   SBP decreased to <80% of the baseline value

2. Inferior vena cava collapsibility index [5 to 20 minutes after subarachnoid block]

   CI = (dIVCmax - dIVCmin)/dIVCmax

Secondary Outcome Measures

1. The incidence of nausea and vomiting [1 to 20 minutes after subarachnoid block]

   Presence of nausea and vomiting in patients after subarachnoid block

2. The incidence of bradycardia [1 to 20 minutes after subarachnoid block]

   Heart rate less than 55 bpm

3. Incidence of hypertension [1 to 20 minutes after subarachnoid block]

   Systolic blood pressure at or above 120% of baseline

4. Arterial base excess of fetal vein blood [Immediately after delivery]

   From umbilical vein blood gases

5. Pressure of oxygen of fetal vein blood [Immediately after delivery]

   From umbilical vein blood gases

6. pH value of fetal vein blood [Immediately after delivery]

   From umbilical vein blood gases

7. Number of rescue norepinephrine [Immediately to 20 minutes after subarachnoid block]

   a bolus of norepinephrine was given when SBP decreased to <80% of the baseline value

8. APGAR score [1min after delivery]

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

9. APGAR score [5min after delivery]

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

10. APGAR score [10min after delivery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18-45 years

• American Society of Anesthesiologists physical status classification I to II

• Scheduled for elective cesarean delivery under spinal anesthesia

• Full-term, singleton, pregnant women

Exclusion Criteria:

• Height of no more than 150 centimeters

• Body weight greater than 100 kg or BMI greater than 30

• Labor analgesia had been performed

• Contraindication of spinal or epidural anesthesia

• Eclampsia or chronic hypertension or baseline blood pressure ≥160mmHg

• Hemoglobin <7g/dl

• Fetal distress or known abnormal fetal development

• Severe vascular disease

• Diabetes mellitus or cardiovascular disease or nervous system disease

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., [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: General Hospital of Ningxia Medical University
• ClinicalTrials.gov Identifier: NCT03997500
• Other Study ID Numbers: Yi Chen
• First Posted: Jun 25, 2019
• Last Update Posted: Feb 17, 2020
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Norepinephrine; Hypotension; Inferior Vena Cava Collapsibility Index; Cesarean Delivery
• Additional relevant MeSH terms: Hypotension; Norepinephrine

Study Results

No Results Posted as of Feb 17, 2020