NCT03792906

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2019

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

January 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

January 18, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2019

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

January 2, 2019

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 (8)

  • 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.

    2 hours after subarachnoid block

  • Heart rate

    2 hours after subarachnoid block

  • Apgar score for evaluation of the activity of the fetus

    10 minutes

  • +3 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: Norepinephrine infusionDrug: Bupivacaine hydrochloride

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: Norepinephrine infusionDrug: Bupivacaine hydrochloride

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
Norepinephrine infusionDRUG

Prophylactic norepinephrine infusion will be started after subarachnoid block.

Also known as: Levophed
Norepinephrine 10 mcgNorepinephrine 6 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

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

Location

Related Publications (1)

  • Hassabelnaby YS, Hasanin AM, Adly N, Mostafa MMA, Refaat S, Fouad E, Elsonbaty M, Hussein HA, Mahmoud M, Abdelwahab YM, Elsakka A, Amin SM. Comparison of two Norepinephrine rescue bolus for Management of Post-spinal Hypotension during Cesarean Delivery: a randomized controlled trial. BMC Anesthesiol. 2020 Apr 17;20(1):84. doi: 10.1186/s12871-020-01004-y.

    PMID: 32303180DERIVED

MeSH Terms

Interventions

NorepinephrineBupivacaine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsAnilidesAmidesAniline Compounds

Study Officials

  • Ahmed M Hasanin, Professor

    Assistant professor of anesthesia

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 4, 2019

Study Start

January 18, 2019

Primary Completion

April 25, 2019

Study Completion

May 1, 2019

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)