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CompletedNCT02854787NorPNUpdated Oct 26, 2017

Intravenous Bolus of Phenylephrine vs. Norepinephrine in Preventing Hypotension After Spinal Anesthesia

A Phase 4 interventional study of Phenylephrine and Norepinephrine in Anesthesia, Spinal and Epidural, Adverse Effect and Hypotension, sponsored by University Tunis El Manar. Completed at 1 site in Tunisia. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-26.

Sponsored by University Tunis El Manar · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study summary

The purpose of the study is to determine if an intravenous bolus of phenylephrine is more effective compared to an intravenous bolus of norepinephrine 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 sufentanil. 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.

Read the 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: An intravenous bolus of 0,2 mcg/Kg of norepinephrine to maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal.

Group B will consist of: An intravenous bolus of 100mcg of phenylephrine 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.

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 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 Phenylephrine or norepinephrine bolus. 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, incidence of nausea and vomiting (NV), incidence of arrhythmia and fetal cord blood analysis (pH) at delivery.

02

Conditions studied

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

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Keywords

  • Spinal anesthesia
  • cesarean
  • blood pressure
  • Norepinephrine
  • Phenylephrine
03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's planned enrollment of 120 is above the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

University Tunis El Manar is the lead sponsor of 73 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • of Anesthesiologists (ASA) Physical Status classification 1 and 2
  • Pregnant women with singleton pregnancy

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Phenylephrine

    A bolus of 100 mcg

    Drug: Phenylephrine

  • Active comparator
    Norepinephrine

    A bolus of 0,2 mcg/kg

    Drug: Norepinephrine

Interventions

  • DrugPhenylephrine

    A bolus of 100 mcg

  • DrugNorepinephrine

    A bolus of 0,2 mcg/kg

    Also known as: Noraline, Noradrénaline

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What researchers measure

Primary outcomes

  1. Maternal Blood Pressure

    Measurement of systolic, diastolic and mean, non-invasive blood pressure during cesarean section with an infusion of either Ephedrine or Norepinephrine

    Time frame: At time of surgery (right after spinal anesthesia until end of surgery)

Secondary outcomes

  1. Hemodynamic Parameters - heart rate

    mean heart rate during cesarean section with an infusion of either Ephedrine or Norepinephrine

    Time frame: At time of surgery (right after spinal anesthesia until end of surgery

  2. Hemodynamic Parameters - arrhythmia

    incidence of arrhythmic events during cesarean section with an infusion of either Ephedrine or Norepinephrine

    Time frame: At time of surgery (right after spinal anesthesia until end of surgery)

  3. Vomiting

    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

    Time frame: At time of surgery (right after spinal anesthesia until end of surgery)

  4. mean pH of the fetal cord blood in each group

    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

    Time frame: At time of birth

  5. Nausea

    cesarean section with an infusion of either Ephedrine or Norepinephrine. Measure will be done according to a simple scale: 0= no nausea; 1= nausea

    Time frame: At time of surgery (right after spinal anesthesia until end of surgery)

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Study locations

1 site
  • Tunis maternity and neonatology center, minisetry of public health
    Tunis, 1007, Tunisia
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02854787
Lead sponsor
University Tunis El Manar
Responsible party
Ben marzouk Sofiene (MD, assistant professor, University Tunis El Manar) — Principal investigator
First posted
Aug 3, 2016
Start date
May 2016
Primary completion
Sep 2016
Completion
Dec 2016
Last update
Oct 26, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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