Back to resultsNorepinephrine and Phenylephrine for Maternal Cardiac Output During Spinal Anesthesia for Elective Cesarean Delivery
Primary Purpose
Hypotension
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Norepinephrine
Phenylephrine
Sponsored by
About this trial
This is an interventional treatment trial for Hypotension
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.
Sites / Locations
- Jeju National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
norepinephrine
phenylephrine
Arm Description
norepinephrine 5mcg intravenously administered
phenylephrine 100mcg intravenously administered
Outcomes
Primary Outcome Measures
change of cardiac index (L/min/m2)
Change from Baseline at time 2, 3, 4, and 5
Secondary Outcome Measures
change of Stroke volume (ml/beat)
Change from Baseline at time 2, 3, 4, and 5
change of Total Peripheral Resistance (dynes sec/cm3)
Change from Baseline at time 2, 3, 4, and 5
change of Systolic blood pressure (mmHg)
Change from Baseline at time 2, 3, 4, and 5
change of heart rate (beats per minute)
Change from Baseline at time 2, 3, 4, and 5
Full Information
NCT ID
NCT02969239
First Posted
October 13, 2016
Last Updated
March 8, 2017
Sponsor
Jeju National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02969239
Brief Title
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jeju National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
norepinephrine
Arm Type
Experimental
Arm Description
norepinephrine 5mcg intravenously administered
Arm Title
phenylephrine
Arm Type
Active Comparator
Arm Description
phenylephrine 100mcg intravenously administered
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
vasopressor given
Intervention Description
bolus administered norepinephrine 5mcg intravenously, if SBP <90mmHg or 20% decrease from baseline
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
vasopressor given
Intervention Description
bolus administered phenylephrine 100mcg intravenously, if SBP <90mmHg or 20% decrease from baseline
Primary Outcome Measure Information:
Title
change of cardiac index (L/min/m2)
Description
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
Secondary Outcome Measure Information:
Title
change of Stroke volume (ml/beat)
Description
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
Title
change of Total Peripheral Resistance (dynes sec/cm3)
Description
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
Title
change of Systolic blood pressure (mmHg)
Description
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
Title
change of heart rate (beats per minute)
Description
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
Other Pre-specified Outcome Measures:
Title
Apgar score
Time Frame
1 min after baby out, 5 min after baby out
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AE RYOUNG LEE
Phone
+82647171810
Email
nanrong95@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Jung Kim
Phone
+82647172031
Email
aeryoung.lee@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AE RYOUNG LEE
Organizational Affiliation
Jeju National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Jeju National University Hospital
City
Jeju
ZIP/Postal Code
690-767
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AE RYOUNG LEE
Phone
+82647171810
Email
nanrong95@naver.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Norepinephrine and Phenylephrine for Maternal Cardiac Output During Spinal Anesthesia for Elective Cesarean Delivery
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