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

Phase 4

• Conditions: Hypotension
• Interventions: Drug: Norepinephrine; Drug: Phenylephrine

• Registration Number: NCT02969239
• Lead Sponsor: Jeju National University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-11-17
• Study First Posted: 2016-11-21
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-10
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
norepinephrine	Norepinephrine	norepinephrine 5mcg intravenously administered
phenylephrine	Phenylephrine	phenylephrine 100mcg intravenously administered

Primary Outcome Measures

Name	Time	Method
change of cardiac index (L/min/m2)	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 from Baseline at time 2, 3, 4, and 5

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jeju National University Hospital; 🇰🇷 Jeju, Korea, Republic of