NCT03712111

Brief Summary

In this study the investigators will compare the efficacy and side effects of two doses of norepinephrine bolus (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during Cesarean delivery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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 16, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 21, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

3.6 years

First QC Date

October 16, 2018

Last Update Submit

September 22, 2021

Conditions

Cesarean Section ComplicationsSpinal Anesthetic Toxicity

Outcome Measures

Primary Outcomes (1)

  • Rate of successful management of maternal hypotension

    number of patients with successful management of maternal hypotensive episode (defined as return of systolic blood pressure to be ≥ 80% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus)

    30 minutes after spinal anesthesia

Secondary Outcomes (7)

  • Rate of successful management of severe maternal hypotension

    30 minutes after spinal anesthesia

  • incidence of reactive hypertension

    30 minutes after spinal anesthesia

  • systolic blood pressure

    90 minutes after spinal anesthesia

  • heart rate

    90 minutes after spinal block

  • Apgar score for evaluation of the activity of the fetus

    10 minutes

  • +2 more secondary outcomes

Study Arms (2)

Norepinephrine 6 mcg

EXPERIMENTAL

Mothers in this group will receive a bolus of Norepinephrine 6 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion

Drug: Norepinephrine 6 mcgDrug: Bupivacaine HydrochlorideDrug: Norepinephrine infusion

Norepinephrine 10 mcg

ACTIVE COMPARATOR

Mothers in this group will receive a bolus of Norepinephrine 10 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion

Drug: Norepinephrine 10 mcgDrug: Bupivacaine HydrochlorideDrug: Norepinephrine infusion

Interventions

Norepinephrine 6 mcgDRUG

An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.

Also known as: Levophed
Norepinephrine 6 mcg
Norepinephrine 10 mcgDRUG

An intravenous bolus of norepinephrine 10 mcg will be administered for management of maternal hypotension.

Also known as: Levophed
Norepinephrine 10 mcg
Bupivacaine HydrochlorideDRUG

Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg

Also known as: Marcaine
Norepinephrine 10 mcgNorepinephrine 6 mcg
Norepinephrine infusionDRUG

Prophylactic norepinephrine infusion will be started after subarachnoid block

Also known as: Levophed
Norepinephrine 10 mcgNorepinephrine 6 mcg

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women
  • scheduled for cesarean delivery

You may not qualify if:

  • patients with severe cardiac dysfunction
  • patients with low blood pressure
  • patients with ante-partum bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

RECRUITING

MeSH Terms

Interventions

NorepinephrineBupivacaine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsAnilidesAmidesAniline Compounds

Study Officials

  • Ahmed Hasanin, Professor

    Assistant professor of anesthesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Amin, Lecturer

CONTACT

+201227476617sarahamin_22@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of anesthesia and critical care

Study Record Dates

First Submitted

October 16, 2018

First Posted

October 19, 2018

Study Start

November 21, 2018

Primary Completion

June 25, 2022

Study Completion

July 1, 2022

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)