NCT03182088

Brief Summary

three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
284

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 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

June 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2017

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

June 7, 2017

Last Update Submit

August 23, 2018

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • 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 (11)

  • severe postspinal hypotension

    30 minutes after spinal anesthesia

  • Post-delivery hypotension

    10 minutes after delivery

  • systolic blood pressure

    60 minutes after spinal block

  • diastolic blood pressure

    60 minutes after spinal block

  • heart rate

    60 minutes after spinal block

  • +6 more secondary outcomes

Study Arms (3)

0.025 mcg /Kg/min group

EXPERIMENTAL

The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.05 mcg/Kg/min) equivalent to norepinephrine infusion (0.025 mcg/Kg/min).

Drug: norepinephrine infusion (0.025 mcg/Kg/min)Drug: Bupivacaine

0.050 mcg/Kg/min group

EXPERIMENTAL

The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.1 mcg/Kg/min) equivalent to norepinephrine infusion (0.050 mcg/Kg/min).

Drug: norepinephrine infusion (0.050 mcg/Kg/min)Drug: Bupivacaine

0.075 mcg/Kg/min group

EXPERIMENTAL

The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.15 mcg/Kg/min) equivalent to norepinephrine infusion (0.075 mcg/Kg/min)

Drug: norepinephrine infusion (0.075 mcg/Kg/min)Drug: Bupivacaine

Interventions

norepinephrine infusion (0.025 mcg/Kg/min)DRUG

The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine bitartrate infusion of (0.05 mcg/Kg/min) equivalent to norepinephrine base of (0.025 mcg/Kg/min)

Also known as: noradrenaline infusion
0.025 mcg /Kg/min group
norepinephrine infusion (0.050 mcg/Kg/min)DRUG

The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.1 mcg/Kg/min) equivalent to norepinephrine base of (0.050 mcg/Kg/min)

Also known as: noradrenaline infusion
0.050 mcg/Kg/min group
norepinephrine infusion (0.075 mcg/Kg/min)DRUG

The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.15 mcg/Kg/min) equivalent to norepinephrine base of (0.075 mcg/Kg/min).

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

The patient will receive spinal anesthesia using Bupivacaine (10 mg).

Also known as: spinal anesthesia, Heavy marcaine
0.025 mcg /Kg/min group0.050 mcg/Kg/min group0.075 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

You may not qualify if:

  • cardiac morbidities
  • hypertensive disorders of pregnancy
  • peripartum bleeding
  • baseline systolic blood pressure (SBP) \< 100 mmHg
  • body mass index \> 35 will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

BupivacaineAnesthesia, Spinal

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 7, 2017

First Posted

June 9, 2017

Study Start

June 15, 2017

Primary Completion

December 25, 2017

Study Completion

December 30, 2017

Last Updated

August 24, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)