Norepinephrine and Phenylephrine for Maternal Cardiac Output During Spinal Anesthesia for Elective Cesarean Delivery

Norepinephrine and Phenylephrine for Cesarean Section

The purpose of this study is to compare norepinephrine and phenylephrine on the effects of maintaining the cardiac output in Cesarean section under spinal anesthesia.

Study Overview

• Status: Unknown
• Conditions: Hypotension
• Intervention / Treatment: Drug: Norepinephrine; Drug: Phenylephrine

Detailed Description

CO was measured using the NICOM® monitor. Bioreactance, a development from impedance technology, is also emerging as an accessible mode of continuous CO monitoring in the operating room and can provide valuable insight into the hemodynamic effects of our interventions. This method of monitoring provides continuous CO, stroke volume (SV) and heart rate (HR) monitoring, and intermittent BP and SVR assessments at 1-minute intervals.

Either phenylephrine (100 mcg/ml) or norepinephrine (0.5 mcg/ml) in 50-ml syringe that were labeled "study drug". She was not involved in patient's care or study assessment.

The hypotension was defined as systolic blood pressure <80% of baseline or < 90 mmHg, and managed with study drug (1 ml) intravenously. The bradycardia was defined as HR < 60 beats/min and was recorded and managed with atropine (0.5 mg) intravenously as HR < 45 beats/min. The presence of nausea and vomiting was measured on a 3 point scale (1 = no nausea and vomiting, 2 = nausea only, and 3 = both nausea and vomiting) and managed with ondansetron (4mg) intravenously.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: AE RYOUNG LEE; Phone Number: +82647171810; Email: nanrong95@naver.com
• Study Contact Backup: Name: Hyun Jung Kim; Phone Number: +82647172031; Email: aeryoung.lee@gmail.com

Study Locations

• Korea, Republic of
  • Jeju, Korea, Republic of, 690-767
    • Recruiting
    • Jeju National University Hospital
    • Contact: AE RYOUNG LEE; Phone Number: +82647171810; Email: nanrong95@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA class I and II, term pregnancy (gestational age>37weeks), planned spinal anesthesia for elective cesarean section

Exclusion Criteria:

• preexisting or gestational hypertension, cerebrovascular or cardiovascular disease, any contraindication to the spinal anesthesia, fetal anormaly, weight<50kg or >100kg, and height<140cm or >180cm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: norepinephrine; norepinephrine 5mcg intravenously administered	Drug: Norepinephrine; bolus administered norepinephrine 5mcg intravenously, if SBP <90mmHg or 20% decrease from baseline; Other Names: vasopressor given
Active Comparator: phenylephrine; phenylephrine 100mcg intravenously administered	Drug: Phenylephrine; bolus administered phenylephrine 100mcg intravenously, if SBP <90mmHg or 20% decrease from baseline; Other Names: vasopressor given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of cardiac index (L/min/m2)	Change from Baseline at time 2, 3, 4, and 5	1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of Stroke volume (ml/beat)	Change from Baseline at time 2, 3, 4, and 5	1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
change of Total Peripheral Resistance (dynes sec/cm3)	Change from Baseline at time 2, 3, 4, and 5	1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
change of Systolic blood pressure (mmHg)	Change from Baseline at time 2, 3, 4, and 5	1. initial (baseline); 2. 20 min after spinal anesthesia; 3. begin the surgery; 4. baby out; 5. the end of surgery
change of heart rate (beats per minute)	Change from Baseline at time 2, 3, 4, and 5	1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery

Other Outcome Measures

Outcome Measure	Time Frame
Apgar score	1 min after baby out, 5 min after baby out

Collaborators and Investigators

• Sponsor: Jeju National University Hospital
• Investigators: Study Director: AE RYOUNG LEE, Jeju National University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 21, 2016

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Norepinephrine; Phenylephrine; Oxymetazoline; Vasoconstrictor Agents
• Other Study ID Numbers: ALee-OB-2016-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No