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

Sponsor

University Tunis El Manar (Other)

Overall Status

Completed

CT.gov ID

NCT02477501

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Adverse Effect, Spinal and Epidural Hypotension Complications; Cesarean Section	Drug: Norepinephrine Drug: Ephedrine	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ephedrine A continuous Ephedrine infusion at 10 mcg/kg/min	Drug: Ephedrine continuous infusion
Active Comparator: Norepinephrine A continuous Norepinephrine infusion at 0.1 mcg/kg/min	Drug: Norepinephrine continuous infusion Other Names: Noradrenaline, Noraline

Arm

Intervention/Treatment

Active Comparator: Ephedrine

A continuous Ephedrine infusion at 10 mcg/kg/min

Drug: Ephedrine

continuous infusion

Active Comparator: Norepinephrine

A continuous Norepinephrine infusion at 0.1 mcg/kg/min

Drug: Norepinephrine

continuous infusion

Other Names:

Noradrenaline, Noraline

Outcome Measures

Primary Outcome Measures

Maternal Blood Pressure [At time of surgery (right after spinal anesthesia untill end of surgery)]
Measurement of systolic, diastolic and mean, non-invasive blood pressure during cesarean section with an infusion of either Ephedrine or Norepinephrine

Secondary Outcome Measures

Hemodynamic Parameters - heart rate [At time of surgery (right after spinal anesthesia untill end of surgery)]
mean heart rate during cesarean section with an infusion of either Ephedrine or Norepinephrine
Hemodynamic Parameters - arrhythmia [AT TIME OF SURGERY(right after spinal anesthesia untill end of surgery)]
incidence of arrhythmic events during cesarean section with an infusion of either Ephedrine or Norepinephrine
Vomiting [AT TIME OF SURGERY (right after spinal anesthesia untill end of surgery)]
incidence of Vomiting (V) during cesarean section with an infusion of either Ephedrine or Norepinephrine. Measure will be done according to a simple scale: 0= no vomiting; 1= vomiting
mean pH of the fetal cord blood in each group [At time of birth]
fetal cord blood analysis will be done immediately after delivery in order to determine the pH value ( ie: logarithm of the blood concentration of hydrogen ions H+)in each group
Nausea [AT TIME OF SURGERY (right after spinal anesthesia untill end of surgery)]
incidence of Nausea (N) during cesarean section with an infusion of either Ephedrine or Norepinephrine. Measure will be done according to a simple scale: 0= no nausea; 1= nausea

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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