NCT03163914

Brief Summary

160 pregnant patients will be enrolled in this study. Participants will divide in to 4 groups. Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl to the all patients. After performed spinal anaesthesia, vasopressor infusion will be started intravenously. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group NE and 0.9% saline (group S) was launched immediately after induction of spinal anesthesia. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group P. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus ephedrine will apply intravenously (IV). If heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply IV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 11, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 19, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2018

Completed
Last Updated

October 24, 2019

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

May 11, 2017

Last Update Submit

October 22, 2019

Conditions

Spinal Anesthesia

Keywords

vasopressorspinal anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of intraoperative maternal hypotension

    The incidence of hypotension (described as less than 80% of baseline (prenatal) SBP or SBP \<90 mm Hg), the total number of hypotension episodes during surgery

    At the time from start of vasopressor infusion till the end of surgery. The time frame is approximately 1 hour, peroperatively.

Study Arms (4)

Epinephrine

ACTIVE COMPARATOR

Epinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h.

Drug: Epinephrine

Norepinephrine

ACTIVE COMPARATOR

Norepinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h.

Drug: Norepinephrine

Phenylephrine

ACTIVE COMPARATOR

Phenylephrine will prepare as 100 µg/ ml and phenylephrine infusion rate will adjust 30 ml/h.

Drug: Phenylephrine

Control

PLACEBO COMPARATOR

Saline infusion will apply at equivalent volume till the surgical operation

Drug: Saline

Interventions

EpinephrineDRUG

Epinephrine infusion rate will adjust 30 ml/h (5µg/ ml )

Also known as: group I
Epinephrine
NorepinephrineDRUG

Norepinephrine infusion rate will adjust 30 ml/h (5µg/ ml )

Also known as: group II
Norepinephrine
PhenylephrineDRUG

Phenylephrine infusion rate will adjust 30 ml/h (100µg/ ml )

Also known as: group III
Phenylephrine
SalineDRUG

saline infusion will apply till the end of the surgery

Also known as: group IV
Control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant patients
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I-II physical status
  • Pregnant patients
  • Full term pregnant

You may not qualify if:

  • ASA III-IV physical status
  • Emergency status
  • Heart disease
  • Hypertension
  • Body mass index\>25

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çukurova University Balcalı Hospital

Adana, 01380, Turkey (Türkiye)

Location

MeSH Terms

Interventions

EpinephrineNorepinephrinePhenylephrineSodium Chloride

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Hakkı Ünlügenç

    Cukurova University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Partipicants and care providers will not known which medication will apply.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 23, 2017

Study Start

July 19, 2017

Primary Completion

April 24, 2018

Study Completion

April 24, 2018

Last Updated

October 24, 2019

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)