NCT02969239

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

October 13, 2016

Last Update Submit

March 8, 2017

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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 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 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 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

Other Outcomes (1)

  • Apgar score

    1 min after baby out, 5 min after baby out

Study Arms (2)

norepinephrine

EXPERIMENTAL

norepinephrine 5mcg intravenously administered

Drug: Norepinephrine

phenylephrine

ACTIVE COMPARATOR

phenylephrine 100mcg intravenously administered

Drug: Phenylephrine

Interventions

NorepinephrineDRUG

bolus administered norepinephrine 5mcg intravenously, if SBP \<90mmHg or 20% decrease from baseline

Also known as: vasopressor given
norepinephrine
PhenylephrineDRUG

bolus administered phenylephrine 100mcg intravenously, if SBP \<90mmHg or 20% decrease from baseline

Also known as: vasopressor given
phenylephrine

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA class I and II, term pregnancy (gestational age\>37weeks), planned spinal anesthesia for elective cesarean section

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeju National University Hospital

Jeju City, Jeju-do, 690-767, South Korea

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

NorepinephrinePhenylephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • AE RYOUNG LEE

    Jeju National University Hospital

    STUDY DIRECTOR

Central Study Contacts

AE RYOUNG LEE

CONTACT

+82647171810nanrong95@naver.com

Hyun Jung Kim

CONTACT

+82647172031aeryoung.lee@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 13, 2016

First Posted

November 21, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations

KR(1)