Clinical trial NCT02969239: Norepinephrine and Phenylephrine for Maternal Cardiac Output During Spinal Anesthesia for Elective Cesarean Delivery
Official title: Norepinephrine and Phenylephrine for Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypotension
Lead sponsor: Jeju National University Hospital
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change of cardiac index (L/min/m2)
timeFrame: 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 outcomes:
measure: change of Stroke volume (ml/beat)
timeFrame: 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
measure: change of Total Peripheral Resistance (dynes sec/cm3)
timeFrame: 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
measure: change of Systolic blood pressure (mmHg)
timeFrame: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. begin the surgery; 4. baby out; 5. the end of surgery
measure: change of heart rate (beats per minute)
timeFrame: 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 outcomes:
measure: Apgar score
timeFrame: 1 min after baby out, 5 min after baby out
Locations:
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
Study officials:
affiliation: Jeju National University Hospital
name: AE RYOUNG LEE
role: STUDY_DIRECTOR
References: