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

Hypotension Clinical Trial

Official title:

Norepinephrine and Phenylephrine for Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02969239
• Other study ID #: ALee-OB-2016-1
• Status: Recruiting
• Phase: Phase 4
• First received: October 13, 2016
• Last updated: March 8, 2017
• Start date: January 2016
• Est. completion date: July 2017

Study information

• Verified date: March 2017
• Source: Jeju National University Hospital
• Contact: AE RYOUNG LEE
• Phone: +82647171810
• Email: nanrong95[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension

Intervention

Drug:
• Norepinephrine
bolus administered norepinephrine 5mcg intravenously, if SBP <90mmHg or 20% decrease from baseline
• Phenylephrine
bolus administered phenylephrine 100mcg intravenously, if SBP <90mmHg or 20% decrease from baseline

Locations

Country	Name	City	State
Korea, Republic of	Jeju National University Hospital	Jeju

Sponsors (1)

Lead Sponsor	Collaborator
Jeju National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Apgar score		1 min after baby out, 5 min after baby out
Primary	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	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
Secondary	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
Secondary	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
Secondary	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