10 Vs.15 mcg Norepinephrine Bolus in Severe Maternal Hypotension During Cesarean Delivery

NCT06512415 | Not Yet Recruiting

• 1 other identifier: MS-421-2022
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

Data regarding the optimum dose of norepinephrine for management of severe maternal hypotension is lacking. A previous report showed that the use of 10-mcg norepinephrine bolus was not superior to the 5-mcg bolus in the management of severe hypotension in addition the incidence of reactive bradycardia and hypertension was comparable in the two doses. Therefore, we hypothesize that using a higher dose of norepinephrine (15 mcg) would increase the success rate of management of severe hypotensive episode.

Conditions

Hypotension; Spinal Anesthesia; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• the incidence of successful management of severe post-spinal hypotension

  systolic blood pressure \>80% of baseline after drug bolus

  1 min after spinal anesthesia until 5 min after the delivery

Secondary Outcomes (7)

• time to severe hypotensive episode

  1 min after spinal anesthesia until 5 min after the delivery

• reactive bradycardia

  1 min after spinal anesthesia until 5 min after the delivery

• reactive hypertension

  1 min after spinal anesthesia until 5 min after the delivery

• umbilical blood pH

  5 min after delivery

• Apgar score

  5 min after delivery

Study Arms (2)

10 mcg group

ACTIVE COMPARATOR

patient will receive the study dry once developed severe post-spinal hypotension

Drug: 10 mcg Norepinephrine

15 mcg group

ACTIVE COMPARATOR

patients will receive the study dry once developed severe post-spinal hypotension

Drug: 15 mcg Norepinephrine

Interventions

10 mcg Norepinephrine DRUG

The assigned dose (10 mcg) will be diluted with normal saline in a 10-cc syringe

10 mcg group

15 mcg Norepinephrine DRUG

The assigned dose (15 mcg) will be diluted with normal saline in a 10-cc syringe.

15 mcg group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• full-term singleton pregnant women
• American society of anesthesiologist II, scheduled for elective cesarean delivery,

You may not qualify if:

• Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction \< 50%, heart block, and arrhythmias),
• hypertensive disorders of pregnancy,
• peripartum bleeding,
• coagulation disorders (patients with INR \>1.4 and or platelet count \< 80000 /dL) or any contraindication to regional anesthesia,
• baseline systolic blood pressure (SBP) \< 100 mmHg

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Hypotension

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

EG (1)