NCT03302039

Brief Summary

The investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension occurred) and single shot (1.5 mcg/Kg) phenylephrine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
217

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 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 1, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

October 6, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
Last Updated

December 17, 2018

Status Verified

December 1, 2018

Enrollment Period

12 months

First QC Date

October 1, 2017

Last Update Submit

December 13, 2018

Conditions

Cesarean Section ComplicationsSpinal Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of Post-spinal anesthesia hypotension

    Defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus

    30 minutes after spinal anesthesia

Secondary Outcomes (8)

  • Incidence of severe Post-spinal anesthesia hypotension

    30 minutes after spinal anesthesia

  • Incidence of reactive hypertension

    2 hours after spinal anesthesia

  • Systolic blood pressure

    2 hours after spinal anesthesia

  • Diastolic blood pressure

    2 hours after spinal anesthesia

  • Heart rate

    2 hours after spinal anesthesia

  • +3 more secondary outcomes

Study Arms (3)

Single shot

EXPERIMENTAL

Spinal anesthesia will be performed using intrathecal bupivacaine. Then, a single shot phenylephrine (1.5 ug/Kg) will be administered.

Drug: Single shot phenylephrineDrug: Bupivacaine

Fixed infusion

ACTIVE COMPARATOR

Spinal anesthesia will be performed using intrathecal bupivacaine. Then, fixed infusion phenylephrine will be administered at a dose of (0.75 mcg/Kg/min). the infusion will stop if reactive hypertension occurred.

Drug: Fixed infusion phenylephrine.Drug: Bupivacaine

Variable infusion

ACTIVE COMPARATOR

Spinal anesthesia will be performed using intrathecal bupivacaine. Then, variable infusion phenylephrine will be administered at a starting dose of (0.75 mcg/Kg/min). the infusion will be titrated according to blood pressure.

Drug: Variable infusion phenylephrine.Drug: Bupivacaine

Interventions

Single shot phenylephrineDRUG

A single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously.

Also known as: Phenylephrine
Single shot
Fixed infusion phenylephrine.DRUG

Fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min

Also known as: Phenylephrine
Fixed infusion
Variable infusion phenylephrine.DRUG

Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.

Also known as: Phenylephrine
Variable infusion
BupivacaineDRUG

Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia.

Also known as: Marcaine
Fixed infusionSingle shotVariable infusion

Eligibility Criteria

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

You may qualify if:

  • Full term
  • Pregnant women
  • Scheduled for cesarean delivery

You may not qualify if:

  • Pre-eclampsia
  • Eclampsia
  • Hemorrhage
  • Cardiac dysfunction
  • Baseline low heart rate (below 60 bpm)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

PhenylephrineBupivacaine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesAnilidesAmidesAniline Compounds

Study Officials

  • Ahmed 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, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 1, 2017

First Posted

October 4, 2017

Study Start

October 6, 2017

Primary Completion

October 1, 2018

Study Completion

October 15, 2018

Last Updated

December 17, 2018

Record last verified: 2018-12

Locations

EG(1)