Comparison of Two Doses of Norepinephrine in Preventing Hypotension After Spinal Anesthesia

June 8, 2025 updated by: Ben marzouk Sofiene, University Tunis El Manar

Comparison of Two Doses of Norepinephrine in Preventing Hypotension After Spinal Anesthesia for Cesarean Section

The purpose of the study is to determine the more effective intravenous bolus of norepinephrine for maintaining blood pressure during a spinal anesthesia for a cesarean delivery with the fewer side effects. Low blood pressure has been shown to decrease uterine perfusion and foetal outcomes during cesarean delivery under spinal anesthesia. For elective or semi-urgent cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and either sufentanil or fentanyl. This study plans to enroll 124 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

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

Group A will receive an intravenous bolus of 1mcg/Kg of norepinephrine bitartrate to maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal anesthesia.

Group B will receive an intravenous bolus of 0.5mcg/kg of norepinephrine bitartrate to maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal anesthesia.

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 as the mean of three consecutive SBP measurements taken 3 minutes apart. 500 mL of Lactated Ringer solution will be administered immediately after induction of spinal anesthesia at the outflow rate of 100ml per hour.

The primary endpoints are: the percentage of decrease of systolic blood pressure and mean blood pressure respectively measured by delta SBP and delta MBP before delivery ( difference between baseline and the lowest systolic and mean blood pressure respectively) and during cesarean delivery

The secondary endpoints are:

the timing of the first maternal hypotension (defined as a decrease of SBP >20% of baseline and/or PAS<100mmHg), duration of hypotension, incidence of hypotension, number of rescue boluses, norepinephrine consumption (mean dose of Norepinephrine to maintain blood pressure between 80 and 100 % of baseline values after the primary preventive bolus), maternal adverse effects and fetal outcomes.

Study participants will receive a standard spinal anesthetic consisting of 0.5% hyperbaric bupivacaine (2 mL) with either sufentanil (5 mcg) or fentanyl (50 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 Norepinephrine bolus A or B.

When PAS<80% of baseline or < 100 mmHg a bolus of Norepinephrine will be administrated(half dose A or B).

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, heart rate, number of rescue boluses and Norepinephrine consumption nausea and vomiting will be recorded whenever present during the surgical procedure as well as reactive hypertension (defined as a rise of SBP >20% of baseline or SBP>140mmHg) and arrhythmia. Bradycardia (HR less than 50 BPM) will be treated with Atropine 1mg IV.

Apgar score and fetal cord blood analysis (pH) at delivery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia, 1007
        • Tunis maternity and neonatology center, minisetry of public health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Elective or semi-urgent CD under spinal anesthesia
  • Age over 18 years
  • Healthy singleton pregnancy beyond 36 weeks' gestation
  • American Society of Anesthesiologists (ASA) physical status classification 2
  • Weight 50 to 100 kg, and height 150 to 180 cm

Exclusion Criteria:

  • Emergency CD red code ( extraction time <15 min)
  • Allergy or hypersensitivity to norepinephrine or sulfite
  • Preexisting or pregnancy-induced hypertension, preeclampsia, eclampsia, the use of cardiac medication or medication for blood pressure control
  • multiple gestation
  • Cardiovascular or cerebrovascular disease
  • Fetal abnormalities
  • Suspicion of abnormal placentation
  • History of diabetes mellitus (excluding gestational diabetes)
  • Use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants
  • documented history of postoperative nausea and vomiting, previous gastric bypass surgery, history of chronic opioid use (chronic pain syndrome)
  • Patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: A
group A: will receive 1 mcg/Kg of Norepinephrine intravenously
Drug: Norepinephrine: 1mcg/kg
intervention:Parturients will receive Norepinephrine: a bolus of 1 mcg/Kg immediately after SA (preventive bolus) then they will receive complementary doses of Norepinephrine (half dose: 0.5 mcg/Kg) to maintain systolic blood pressure above 80 % of baseline
Other Names:
  • Noradrenaline
  • Noraline
Active Comparator: B
group B: will receive 0.5 mcg/Kg of Norepinephrine intravenously
Drug: Norepinephrine 0,5mcg/kg
intervention: Parturients will receive Norepinephrine: a bolus of 0.5 mcg/Kg immediately after SA (preventive bolus) then they will receive complementary doses of Norepinephrine (half dose: 0.25 mcg/Kg) to maintain systolic blood pressure above 80 % of baseline
Other Names:
  • Noradrenaline
  • Noraline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
systolic blood pressure variation before delivery
Time Frame: time from immediately after spinal anesthesia until delivery
difference between the baseline systolic blood pressure (SBP0) and the lowest systolic blood pressure (SBPmin) registred before delivery and computed as (SBP min -SBP0)/SBP0
time from immediately after spinal anesthesia until delivery
mean blood pressure variation before delivery
Time Frame: time from immediately after spinal anesthesia until delivery
difference between the baseline mean blood pressure(MBP0) and the lowest mean blood pressure (MBPmin) registred before delivery and computed as (MBP min -MBP0)/MBP0
time from immediately after spinal anesthesia until delivery
systolic blood pressure variation during cesarean delivery
Time Frame: time from immediately after spinal anesthesia until the end of surgery
difference between the baseline systolic blood pressure (SBP0) and the lowest systolic blood pressure (SBPmin) registred during the cesarean section
time from immediately after spinal anesthesia until the end of surgery
mean blood pressure variation during cesarean delivery
Time Frame: time from immediately after spinal anesthesia until the end of surgery
difference between the baseline mean blood pressure (MBP0) and the lowest systolic blood pressure (MBPmin) registred during the cesarean section
time from immediately after spinal anesthesia until the end of surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to administartion of the first rescue bolus
Time Frame: time from immediately after spinal anesthesia until delivery
timing of the first hypotension(defined as a decrease of SBP >20% of baseline and/or PAS<100mmHg) recsue bolus will be given at that moment
time from immediately after spinal anesthesia until delivery
Incidence of hypotension
Time Frame: tile from right after spinal anesthesia until delivery
incidence of hypotension after the primary preventive bolus
tile from right after spinal anesthesia until delivery
Norepinephrine consumption
Time Frame: time fro right after spinal anesthesia until the end of surgery
Mean dose of Norepinephrine ( micrograms) given to maintain blood pressure between 80 and 100 % of baseline values after the primary preventive bolus
time fro right after spinal anesthesia until the end of surgery
Nausea
Time Frame: time of surgery (right after spinal anesthesia until end of surgery)
Incidence of nausea. Measure will be done according to a simple scale: 0= no nausea; 1= nausea [Time
time of surgery (right after spinal anesthesia until end of surgery)
Vomiting
Time Frame: time of surgery (right after spinal anesthesia until end of surgery)
incidence of Vomiting (V) during cesarean section with an infusion of a bolus Norepinephrine. Measure will be done according to a simple scale: 0= no vomiting; 1= vomiting
time of surgery (right after spinal anesthesia until end of surgery)
arrhythmia
Time Frame: time of surgery (right after spinal anesthesia until end of surgery)
incidence of arrhythmic events during cesarean section with an infusion of a bolus of Norepinephrine
time of surgery (right after spinal anesthesia until end of surgery)
Hypertension
Time Frame: right after spinal anesthesia until end of surgery)]
a rise of systolic blood pressure (SBP)>20% of baseline or SBP>140mmHg
right after spinal anesthesia until end of surgery)]
mean pH of the fetal cord blood
Time Frame: 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
time of birth
Apgar score
Time Frame: at time of birth
apgar at 1 and 5 minutes Apgar at 1 and 5 minutes
at time of birth
duration of hypotension
Time Frame: immediately after spinal anesthesia until the end of surgery
duration of each episode of hypotension in minutes
immediately after spinal anesthesia until the end of surgery
number of rescue boluses
Time Frame: immediately after spinal anesthesia until the end of surgery
the number of boluses to treat hypotension
immediately after spinal anesthesia until the end of surgery
Bradycardia
Time Frame: immediately after spinal anesthesia until the end of surgery
heart rate less than 50 BPM
immediately after spinal anesthesia until the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Tunis El Manar

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: HAYEN Hayen maghrebi, professor, University Tunis El Manar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Norepinephrine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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