Ephedrine vs. Nor Epinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Section

NCT ID: NCT02477501

Last Updated: 2017-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-12-31

Brief Summary

The purpose of the study is to determine if norepinephrine is more effective as a continuous intravenous (IV) infusion compared to continuous IV ephedrine associated with crystalloid loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Prevention of low blood pressure has been shown to decrease nausea and vomiting during and after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and morphine. This study plans to enroll 120 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.

Detailed Description

This study will be a prospective, randomized, active treatment controlled trial.

After written and informed consent are obtained, the study participants are randomly assigned using a computer generated table to 1 of 2 treatment groups prior to cesarean delivery.

Group A will consist of: A continuous Ephedrine infusion 10 mcg/kg/min to maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal.

Group B will consist of: A continuous norepinephrine infusion 0.1 mcg/kg/min to maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal.

Patients will be admitted to holding area. Baseline arterial blood pressure and heart rate will be measured in supine position, with left uterine displacement. Baseline blood pressure will be calculated by taking the mean of three consecutive SBP measurements taken 5 minutes apart. 500 mL of Lactated Ringers solution will be administered immediately after induction of spinal anesthesia at the outflow rate of 100ml per hour.

The primary endpoint is the number of provider interventions needed to maintain the SBP within 100-120% of baseline for both groups. The secondary endpoint is nausea measured with each provider intervention after induction of spinal anesthesia, and immediately following delivery with 11 point verbal rating scale (0 = no nausea, 1 = nausea). Vomiting will be recorded whenever present during the surgical procedure.

Hypertensive episodes (SBP greater than 120% of baseline) will be treated with cessation of infusion. Infusion will be restarted when SBP has decreased to below the baseline SBP). If the infusion must be stopped on three occasions, it will be discontinued permanently and the blood pressure maintained with Ephedrine boluses only when needed.

Bradycardia (HR less than 50 BPM) will be treated with Atropine 0.4mg IV or ephedrine 3 mg - 12 mg IV bolus.

Study participants will receive a standard spinal anesthetic consisting of 0.5% hyperbaric bupivacaine (2 mL) plus preservative free morphine (0.1 mg) and sufentanil (5 mcg) at L3-4 or L4-5. Prior to surgical incision, the spinal sensory level will be tested to the bilateral T6-T4 dermatomal level. The patients will be positioned supine with a wedge placed under the right hip to avoid aortocaval compression. Both the patient and the researcher's assistant (who will collect data) will be blinded as to the administered Ephedrine infusion or norepinephrine infusion. The study will end when cesarean section is completed and the patient transferred to the post-operative care unit.

Measured variables will include systolic, diastolic and mean non-invasive blood pressure, the number and type of interventions for control of blood pressure, heart rate, incidedence of nausea and vomiting (NV), incidence of arrhythmia and fetal cord blood analysis (pH) at delivery.

Conditions

Anesthesia; Adverse Effect, Spinal and Epidural; Hypotension; Complications; Cesarean Section

Keywords

Spinal anesthesia; cesarean; blood pressure; Norepinephrine; Ephedrine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Ephedrine

A continuous Ephedrine infusion at 10 mcg/kg/min

Group Type: ACTIVE_COMPARATOR

Ephedrine

Intervention Type: DRUG

continuous infusion

Norepinephrine

A continuous Norepinephrine infusion at 0.1 mcg/kg/min

Group Type: ACTIVE_COMPARATOR

Norepinephrine

Intervention Type: DRUG

continuous infusion

Interventions

Norepinephrine

continuous infusion

Intervention Type: DRUG

Ephedrine

continuous infusion

Intervention Type: DRUG

Other Intervention Names

Noradrenaline, Noraline

Eligibility Criteria

Inclusion Criteria

• The American Society of Anesthesiologists (ASA) Physical Status classification 1 and 2
• Pregnant women with singleton pregnancy
• Gestational age greater than 36 weeks
• Cesarean delivery under spinal anesthesia

Exclusion Criteria

• Use of cardiac medication or medication for blood pressure control
• Cardiovascular disease
• Multiple gestation
• Gestation diabetes requiring insulin
• Refusal to be in study
• History of chronic opioid use (chronic pain syndrome)
• Emergent caesarean delivery for maternal and/or fetal distress
• Preeclampsia
• Eclampsia
• Progressive neurologic disease
• Infection at insertion site
• Allergy to local anesthetics, narcotics or other study medications

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Ben marzouk Sofiene

MD, assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hayen maghrebi, professor

Role: STUDY_DIRECTOR

University Tunis El Manar

Locations

Tunis maternity and neonatology center, minisetry of public health

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

UTEM NAD

Identifier Type: -

Identifier Source: org_study_id