NCT03328533

Brief Summary

Comparison will be conducted between continuous variable infusions of Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) for prophylaxis against Post-spinal hypotension during cesarean delivery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

November 10, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

October 30, 2017

Last Update Submit

July 14, 2018

Conditions

Cesarean Section ComplicationsSpinal Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-spinal anesthesia hypotension.

    Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading

    30 minutes after spinal anesthesia

Secondary Outcomes (13)

  • Incidence of severe post-spinal anesthesia hypotension

    30 minutes after spinal anesthesia

  • Incidence of severe delivery hypotension

    10 minutes after delivery

  • Systolic blood pressure

    2 hours after subarachnoid block

  • Heart rate

    2 hours after subarachnoid block

  • APGAR score for assessment of the general state of the fetus

    10 minutes after delivery

  • +8 more secondary outcomes

Study Arms (2)

Phenylephrine

ACTIVE COMPARATOR

Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.

Drug: PhenylephrineDrug: Bupivacaine

Norepinephrine

EXPERIMENTAL

Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine bitartrate infusion by a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min). The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.

Drug: NorepinephrineDrug: Bupivacaine

Interventions

PhenylephrineDRUG

Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.

Phenylephrine
NorepinephrineDRUG

Norepinephrine bitartrate variable infusion with a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min).

Also known as: Levophed
Norepinephrine
BupivacaineDRUG

Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg.

Also known as: Marcaine
NorepinephrinePhenylephrine

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Full term
  • Pregnant women
  • Scheduled for cesarean section

You may not qualify if:

  • Pre-eclampsia
  • Eclampsia
  • Bleeding
  • Cardiac dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

PhenylephrineNorepinephrineBupivacaine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsAnilidesAmidesAniline Compounds

Study Officials

  • Ahmed M Mukhtar, Professor

    Head of research committee section in anesthesia department

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 1, 2017

Study Start

November 10, 2017

Primary Completion

May 1, 2018

Study Completion

May 5, 2018

Last Updated

July 17, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)