Norepinephrine or Phenylephrine in Bolus for Hypotension in Cesarean Delivery

Phase 2

Completed

• Conditions: Hypotension; Spinal Anesthesia
• Interventions: Drug: Phenylephrine 100 mcg; Drug: Norepinephrine 5 mcg

• Registration Number: NCT03702400
• Lead Sponsor: Hospital dos Servidores do Estado do Rio de Janeiro

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.

Detailed Description

This is a prospective, randomized, double-blind, comparative two-group clinical study to observe two vasopressor drugs, phenylephrine and noradrenaline, in the ability to maintain systemic arterial pressure in pregnant women after spinal anesthesia for cesarean section; based on the hypothesis that, since noradrenaline has a predominant alpha-adrenergic action and a weak 1- beta-adrenergic beta action, it could be as capable of maintaining blood pressure effectively as phenylephrine, but with a lower frequency of bradycardia; patients who meet the inclusion criteria will be randomly assigned to one of the groups to be studied: group F - phenylephrine at a dose of 100mcg bolus and N - noradrenaline at the dose of 5mcg. One of these drugs will be used whenever systolic blood pressure drops below 10% of the baseline, additional doses will be allowed whenever necessary, aiming at maintaining the systolic blood pressure at baseline values; the blood pressure will be measured non-invasively and the heart rate by pulse oximeter and electrocardiogram.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-10-06
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-11
• Primary Completion: 2020-06-01
• Study Completion: 2020-10-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-08
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenylephrine 100 mcg	Phenylephrine 100 mcg	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.
Norepinephrine 5 mcg	Norepinephrine 5 mcg	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.

Primary Outcome Measures

Name	Time	Method
Heart rate	during the procedure	Number of episodes of heart rate under 60 bpm while using phenylephrine and noradrenaline in pregnant women undergoing spinal anesthesia for cesarean
Number of bolus required	during the procedure	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

Secondary Outcome Measures

Name	Time	Method
Neonatal gasometric outcome	during the procedure	To evaluate the neonatal outcome through the analysis of venous and arterial blood gases collected in the cord umbilical after birth.
Neonatal Apgar outcome	during the procedure	To evaluate the neonatal outcome through the classification given by the neonatologist responsible for the care to the newborn in the delivery room with the use of the Apgar Scale (0-10), 10 the better classification.
Nausea and vomiting	during the procedure	To evaluate the incidence of nausea and vomiting of the parturient during cesarean section

Trial Locations

Locations (1)

Hospital Federal Dos Servidores Do Estado; 🇧🇷 Rio De Janeiro, RJ, Brazil