AnesthesiaPhase 4NCT03706755
Comparison of Two Doses of Norepinephrine in Preventing Hypotension After Spinal Anesthesia
A Phase 4 study testing Norepinephrine: 1mcg/kg and Norepinephrine 0,5mcg/kg in people with Anesthesia and Adverse Effect, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Adverse Effect, Hypotension
- What is being tested?
- Norepinephrine: 1mcg/kg and Norepinephrine 0,5mcg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTunisia
- Study dates
- 3 May 2018to 1 Oct 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Tunis maternity and neonatology center, minisetry of public health
Tunis, 1007
About this study
Official title: 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.
Read the 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.
- Being tested
- Norepinephrine: 1mcg/kg, Norepinephrine 0,5mcg/kg
- Keywords
- spinal anesthesia, blood pressure, norepinephrine, Cesarean Section
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine: 1mcg/kgDrug
Also called Noraline, Noradrenaline
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
Norepinephrine 0,5mcg/kgDrug
Also called Noraline, Noradrenaline
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
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | group A: will receive 1 mcg/Kg of Norepinephrine intravenously Receives: Drug: Norepinephrine: 1mcg/kg |
| B | Active comparator | group B: will receive 0.5 mcg/Kg of Norepinephrine intravenously Receives: Drug: Norepinephrine 0,5mcg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure variation before 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
Measured: time from immediately after spinal anesthesia until delivery
mean blood pressure variation before 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
Measured: time from immediately after spinal anesthesia until delivery
systolic blood pressure variation during cesarean delivery
difference between the baseline systolic blood pressure (SBP0) and the lowest systolic blood pressure (SBPmin) registred during the cesarean section
Measured: time from immediately after spinal anesthesia until the end of surgery
mean blood pressure variation during cesarean delivery
difference between the baseline mean blood pressure (MBP0) and the lowest systolic blood pressure (MBPmin) registred during the cesarean section
Measured: time from immediately after spinal anesthesia until the end of surgery
Secondary outcomes (12)
Time to administartion of the first rescue bolus
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
Measured: time from immediately after spinal anesthesia until delivery
duration of hypotension
duration of each episode of hypotension in minutes
Measured: immediately after spinal anesthesia until the end of surgery
number of rescue boluses
the number of boluses to treat hypotension
Measured: immediately after spinal anesthesia until the end of surgery
Incidence of hypotension
incidence of hypotension after the primary preventive bolus
Measured: tile from right after spinal anesthesia until delivery
Norepinephrine consumption
Mean dose of Norepinephrine ( micrograms) given to maintain blood pressure between 80 and 100 % of baseline values after the primary preventive bolus
Measured: time fro right after spinal anesthesia until the end of surgery
Nausea
Incidence of nausea. Measure will be done according to a simple scale: 0= no nausea; 1= nausea [Time
Measured: time of surgery (right after spinal anesthesia until end of surgery)
Vomiting
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
Measured: time of surgery (right after spinal anesthesia until end of surgery)
Bradycardia
heart rate less than 50 BPM
Measured: immediately after spinal anesthesia until the end of surgery
arrhythmia
incidence of arrhythmic events during cesarean section with an infusion of a bolus of Norepinephrine
Measured: time of surgery (right after spinal anesthesia until end of surgery)
Hypertension
a rise of systolic blood pressure (SBP)>20% of baseline or SBP>140mmHg
Measured: right after spinal anesthesia until end of surgery)]
Apgar score
apgar at 1 and 5 minutes Apgar at 1 and 5 minutes
Measured: at time of birth
mean pH of the fetal cord blood
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
Measured: time of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start3 May 2018
- Primary completion2 Sep 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben marzouk Sofiene, University Tunis El Manar
- Investigators
- HAYEN Hayen maghrebi, professor, Study chair, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706755
- Sponsor's protocol ID
- Norepinephrine
- Status last verified
- Jun 2025
- First submitted
- 11 Oct 2018
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Doses of Norepinephrine in Preventing Hypotension After Spinal Anesthesia for Cesarean Section
- ClinicalTrials.gov ID
- NCT03706755
- Acronym / sponsor ID
- Norepinephrine
- Keywords
- spinal anesthesia, blood pressure, norepinephrine, Cesarean Section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 2 Sep 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Norepinephrine: 1mcg/kggroup A: will receive 1 mcg/Kg of Norepinephrine intravenously |
| B | Active comparator | Drug: Norepinephrine 0,5mcg/kggroup B: will receive 0.5 mcg/Kg of Norepinephrine intravenously |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norepinephrine: 1mcg/kgAlso: Noraline, Noradrenalineintervention: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 | Drug | A |
| Norepinephrine 0,5mcg/kgAlso: Noraline, Noradrenalineintervention: 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 | Drug | B |
Primary outcome
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
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
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
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
12 secondary outcomes
Time to administartion of the first rescue bolus
Time frame: time from immediately after spinal anesthesia until delivery
duration of hypotension
Time frame: immediately after spinal anesthesia until the end of surgery
number of rescue boluses
Time frame: immediately after spinal anesthesia until the end of surgery
Incidence of hypotension
Time frame: tile from right after spinal anesthesia until delivery
Norepinephrine consumption
Time frame: 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)
Vomiting
Time frame: time of surgery (right after spinal anesthesia until end of surgery)
Bradycardia
Time frame: immediately after spinal anesthesia until the end of surgery
arrhythmia
Time frame: time of surgery (right after spinal anesthesia until end of surgery)
Hypertension
Time frame: right after spinal anesthesia until end of surgery)]
Apgar score
Time frame: at time of birth
mean pH of the fetal cord blood
Time frame: time of birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HAYEN Hayen maghrebi, professor study chair
University Tunis El Manar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norepinephrine: 1mcg/kg and Norepinephrine 0,5mcg/kg in people with Anesthesia and Adverse Effect, run by University Tunis El Manar at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic blood pressure variation before delivery (time frame: time from immediately after spinal anesthesia until delivery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.