A Phase 4 interventional study of Norepinephrine and Phenylephrine in Hypotension, sponsored by Jeju National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-03-10.
Sponsored by Jeju National University Hospital · Phase 4, Interventional, and Treatment
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.
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →Jeju National University Hospital is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
norepinephrine 5mcg intravenously administered
Drug: Norepinephrine
phenylephrine 100mcg intravenously administered
Drug: Phenylephrine
bolus administered norepinephrine 5mcg intravenously, if SBP \<90mmHg or 20% decrease from baseline
Also known as: vasopressor given
bolus administered phenylephrine 100mcg intravenously, if SBP \<90mmHg or 20% decrease from baseline
Also known as: vasopressor given
change of cardiac index (L/min/m2)
Change from Baseline at time 2, 3, 4, and 5
Time frame: 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 Stroke volume (ml/beat)
Change from Baseline at time 2, 3, 4, and 5
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Apgar score
Time frame: 1 min after baby out, 5 min after baby out
Plan to share: Undecided
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This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Jeju National University Hospital