Norepinephrine or Phenylephrine in Bolus for Hypotension in Cesarean Delivery

NCT03702400 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 000.603
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluate the ability of phenylephrine and of noradrenaline to maintain normal systemic arterial blood pressure and heart rate in healthy pregnant women submitted to cesarean section with spinal anesthesia. Half of participants will receive bolus of phenylephrine while the other half will receive bolus of noradrenaline.

Conditions

Hypotension; Spinal Anesthesia

Keywords

phenylephrine; norepinephrine; cesarean delivery under spinal anesthesia

Outcome Measures

Primary Outcomes (2)

• Number of bolus required

  Number of bolus doses of phenylephrine and noradrenaline to maintain systemic arterial pressure at 90% of baseline in pregnant women undergoing spinal anesthesia for cesarean

  during the procedure

• Heart rate

  Number of episodes of heart rate under 60 bpm while using phenylephrine and noradrenaline in pregnant women undergoing spinal anesthesia for cesarean

  during the procedure

Secondary Outcomes (3)

• Neonatal gasometric outcome

  during the procedure

• Neonatal Apgar outcome

  during the procedure

• Nausea and vomiting

  during the procedure

Study Arms (2)

Phenylephrine 100 mcg

ACTIVE COMPARATOR

Phenylephrine will be used at a dose of 100 mcg bolus at a dilution containing 20 mcg / mL of the drug to be used whenever systolic blood pressure falls below 10% of baseline.

Drug: Phenylephrine 100 mcg

Norepinephrine 5 mcg

EXPERIMENTAL

Norepinephrine will be used at a dose of 5 mcg at a dilution containing 1 mcg / mL to be used whenever systolic blood pressure falls below 10% of baseline.

Drug: Norepinephrine 5 mcg

Interventions

Phenylephrine 100 mcg DRUG

Phenylephrine at a dose of 100 mcg bolus at a dilution containing 20 mcg / mL of the drug, 5 mL each bolus

Also known as: Fenilefrin

Phenylephrine 100 mcg

Norepinephrine 5 mcg DRUG

Norepinephrine at a dose of 5 mcg at dilution containing 1 mcg / mL, 5 mL each bolus

Also known as: Hemitartarato de norepinefrina

Norepinephrine 5 mcg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women, with single gestation, with cesarean programming to be performed under spinal anesthesia;
• Age above 18 years;
• Physical State American Society of Anesthesiologists (ASA) II and III;
• Weight between 50kg and 120kg;
• Height between 140cm and 180cm.

You may not qualify if:

• Refusal to participate in the study;
• Pregnant women with fetus with known abnormalities;
• Pregnant women with cardiovascular disease;
• Pregnant women with pregnancy-specific hypertensive disease;
• Allergy to any medication to be used in the study;
• Users of monoamine oxidase inhibitors;
• Users of tricyclic antidepressants;
• Emergency caesarean section due to acute fetal distress;
• Situations in which the sensory level after single intrathecal injection of the local anesthetic does not reach at least T6 within 5 minutes after spinal anesthesia.

Sponsors & Collaborators

• Hospital dos Servidores do Estado do Rio de Janeiro: lead

Study Sites (1)

Hospital Federal Dos Servidores Do Estado

Rio de Janeiro, Rio de Janeiro, 22451-030, Brazil

Location

Related Publications (2)

• Ngan Kee WD, Lee SW, Ng FF, Tan PE, Khaw KS. Randomized double-blinded comparison of norepinephrine and phenylephrine for maintenance of blood pressure during spinal anesthesia for cesarean delivery. Anesthesiology. 2015 Apr;122(4):736-45. doi: 10.1097/ALN.0000000000000601.

  PMID: 25635593 BACKGROUND

• Vallejo MC, Attaallah AF, Elzamzamy OM, Cifarelli DT, Phelps AL, Hobbs GR, Shapiro RE, Ranganathan P. An open-label randomized controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion in prevention of spinal hypotension during cesarean delivery. Int J Obstet Anesth. 2017 Feb;29:18-25. doi: 10.1016/j.ijoa.2016.08.005. Epub 2016 Aug 28.

  PMID: 27720613 BACKGROUND

MeSH Terms

Conditions

Hypotension

Interventions

Phenylephrine; 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 Officials

• DANIEL V DE QUEIROZ

  HOSPITAL FEDERAL DOS SERVIDORES DO ESTADO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair

Model Details: In a randomized, double-blinded study, 76 healthy patients having cesarean delivery under spinal anesthesia will be randomized, using an electronic system (the Randomizer App®, Version 3.2 Wisse Keizer program), to have systolic blood pressure maintained with bolus of phenylephrine at a dose of 100 mcg bolus (at a dilution containing 20 mcg / mL), or with norepinephrine at a dose of 5 mcg (at a dilution containing 1 mcg / mL).

Study Record Dates

• First Submitted: October 6, 2018
• First Posted: October 11, 2018
• Study Start: October 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)