NCT03234816

Brief Summary

Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean delivery with promising results ; However, the optimum dose for efficient prophylaxis with the least side effects is not known. In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine 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
270

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2017

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

July 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

August 2, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

July 27, 2017

Last Update Submit

January 13, 2019

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • incidence of postspinal hypotension

    The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group

    30 minutes after spinal anesthesia

Secondary Outcomes (8)

  • heart rate

    90 minutes after spinal anesthesia

  • vomiting

    120 minutes after spinal anesthesia

  • nausea

    120 minutes after spinal anesthesia

  • ephedrine consumption

    60 minutes after spinal anesthesia

  • Atropine consumption

    60 minutes after spinal anesthesia

  • +3 more secondary outcomes

Study Arms (3)

- 0.05 mcg /Kg/min group

EXPERIMENTAL

will receive norepinephrine 0.05 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus

Drug: Norepinephrine 0.05 mcg /Kg/minDrug: Bupivacaine

- 0.1 mcg /Kg/min group

EXPERIMENTAL

will receive norepinephrine 0.1 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus

Drug: Norepinephrine 0.1 mcg /Kg/minDrug: Bupivacaine

- 0.15 mcg /Kg/min group

EXPERIMENTAL

will receive norepinephrine 0.15 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus

Drug: Norepinephrine 0.15 mcg /Kg/minDrug: Bupivacaine

Interventions

Norepinephrine 0.05 mcg /Kg/minDRUG

Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia

Also known as: noradrenaline infusion
- 0.05 mcg /Kg/min group
Norepinephrine 0.1 mcg /Kg/minDRUG

Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia

Also known as: noradrenaline infusion
- 0.1 mcg /Kg/min group
Norepinephrine 0.15 mcg /Kg/minDRUG

Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia

Also known as: noradrenaline infusion
- 0.15 mcg /Kg/min group
BupivacaineDRUG

10 mg Bupivacaine intra-thecal for spinal anesthesia

Also known as: marcaine
- 0.05 mcg /Kg/min group- 0.1 mcg /Kg/min group- 0.15 mcg /Kg/min group

Eligibility Criteria

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

You may qualify if:

  • full term singleton pregnant women
  • Scheduled for elective Cesarean Delivery
  • Aged between 18 and 40 years

You may not qualify if:

  • Cardiac morbidities
  • Hypertensive disorders of pregnancy,
  • Peripartum bleeding
  • Baseline systolic blood pressure (SBP) \< 100 mmHg
  • Body mass index \> 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

NorepinephrineBupivacaine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsAnilidesAmidesAniline 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
Principal investigator, Lecturer of anesthesia and critical care medicine

Study Record Dates

First Submitted

July 27, 2017

First Posted

July 31, 2017

Study Start

August 2, 2017

Primary Completion

November 2, 2018

Study Completion

December 10, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)