HypotenstionNorepinephrineNCT07153601
Norepinephrine vs. Phenylephrine for Spinal Hypotension in Cesarean Section
A study testing Norepinephrine 4mcg and Phenylephrine 50 mcg in people with Hypotenstion and Cesarean Resection, run by Universitas Sumatera Utara at 1 site in Indonesia.
Trial summary
This clinical trial was conducted to compare the effectiveness and safety of two medications-norepinephrine and phenylephrine-in treating low blood pressure (hypotension) that often occurs during spinal anesthesia for cesarean section (C-section) deliveries. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypotenstion, Cesarean Resection, Anesthesia Spinal
- What is being tested?
- Norepinephrine 4mcg and Phenylephrine 50 mcg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Feb 2025to 10 May 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients aged 18-40 years
- Undergoing elective cesarean section
- Receiving spinal anesthesia
- Classified as ASA Physical Status II
- Stable baseline hemodynamics prior to anesthesia
- Not using inotropic, chronotropic, or vasoactive drugs before surgery
Who cannot join
- Emergency cesarean section
- Fetal distress
- Preeclampsia or eclampsia
- Contraindications to spinal anesthesia (e.g., coagulopathy, infection at injection site)
- Known allergy to norepinephrine or phenylephrine
- Hemodynamic instability prior to vasopressor administration
- Withdrawal from study or refusal to participate
- Failure to develop post-spinal hypotension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Bolus Doses of Norepinephrine 4 mcg and Phenylephrine 50 mcg in Managing Hypotension After Spinal Anesthesia in Cesarean Section Patients
This clinical trial was conducted to compare the effectiveness and safety of two medications-norepinephrine and phenylephrine-in treating low blood pressure (hypotension) that often occurs during spinal anesthesia for cesarean section (C-section) deliveries. Spinal anesthesia is commonly used during C-sections but can cause a drop in the mother's blood pressure, which may affect both the mother and the baby.
In this study, 46 pregnant women undergoing elective C-sections were randomly given either norepinephrine (4 mcg) or phenylephrine (50 mcg) when their blood pressure dropped. Researchers monitored their heart rate, blood pressure, and any side effects for 30 minutes after anesthesia.
Read more
The results showed that both drugs were effective in raising blood pressure. However, norepinephrine kept the heart rate more stable, while phenylephrine caused a noticeable slowing of the heart rate (bradycardia). Both drugs were safe and well tolerated.
This study suggests that norepinephrine may be a better option for managing low blood pressure during spinal anesthesia in C-sections, especially when maintaining heart rate and cardiac output is important.
- Conditions
- Hypotenstion, Cesarean Resection, Anesthesia Spinal, Pregnancy Complications, Cardiovascular
- Being tested
- Norepinephrine 4mcg, Phenylephrine 50 mcg
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine 4mcgDrug
Norepinephrine 4 mcg IV bolus diluted in 2 mL normal saline, administered upon onset of hypotension during spinal anesthesia.
Phenylephrine 50 mcgDrug
Phenylephrine 50 mcg IV bolus diluted in 2 mL normal saline, administered upon onset of hypotension during spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine Group | Experimental | Participants in this group received intravenous bolus doses of norepinephrine 4 mcg (2 mL) diluted in normal saline to treat spinal anesthesia-induced hypotension during cesarean section. Receives: Drug: Norepinephrine 4mcg |
| Phenylephrine Group | Experimental | Participants in this group received intravenous bolus doses of phenylephrine 50 mcg (2 mL) diluted in normal saline to treat spinal anesthesia-induced hypotension during cesarean section Receives: Drug: Phenylephrine 50 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure (SBP) After Vasopressor Administration
Change in systolic blood pressure measured before vasopressor administration (T0-T1) and two minutes after administration (T2) in response to intravenous bolus of norepinephrine 4 mcg or phenylephrine 50 mcg during spinal anesthesia-induced hypotension in cesarean section patients.
Measured: Baseline to 2 minutes post-administration (T0-T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start7 Feb 2025
- Primary completion10 May 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotenstionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imam Syahputra, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153601
- Sponsor's protocol ID
- 103/KEPK/USU/2025
- Acronym
- Norepinephrine
- Status last verified
- Aug 2025
- First submitted
- 8 Jul 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Bolus Doses of Norepinephrine 4 mcg and Phenylephrine 50 mcg in Managing Hypotension After Spinal Anesthesia in Cesarean Section Patients
- ClinicalTrials.gov ID
- NCT07153601
- Acronym / sponsor ID
- Norepinephrine / 103/KEPK/USU/2025
- Conditions
- Hypotenstion, Cesarean Resection, Anesthesia Spinal, Pregnancy Complications, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 4 Sep 2025 (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.
This clinical trial was conducted to compare the effectiveness and safety of two medications-norepinephrine and phenylephrine-in treating low blood pressure (hypotension) that often occurs during spinal anesthesia for cesarean section (C-section) deliveries. Spinal anesthesia is commonly used during C-sections but can cause a drop in the mother's blood pressure, which may affect both the mother and the baby.
In this study, 46 pregnant women undergoing elective C-sections were randomly given either norepinephrine (4 mcg) or phenylephrine (50 mcg) when their blood pressure dropped. Researchers monitored their heart rate, blood pressure, and any side effects for 30 minutes after anesthesia.
The results showed that both drugs were effective in raising blood pressure. However, norepinephrine kept the heart rate more stable, while phenylephrine caused a noticeable slowing of the heart rate (bradycardia). Both drugs were safe and well tolerated.
This study suggests that norepinephrine may be a better option for managing low blood pressure during spinal anesthesia in C-sections, especially when maintaining heart rate and cardiac output is important.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine Group | Experimental | Drug: Norepinephrine 4mcgParticipants in this group received intravenous bolus doses of norepinephrine 4 mcg (2 mL) diluted in normal saline to treat spinal anesthesia-induced hypotension during cesarean section. |
| Phenylephrine Group | Experimental | Drug: Phenylephrine 50 mcgParticipants in this group received intravenous bolus doses of phenylephrine 50 mcg (2 mL) diluted in normal saline to treat spinal anesthesia-induced hypotension during cesarean section |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients aged 18-40 years
- Undergoing elective cesarean section
- Receiving spinal anesthesia
- Classified as ASA Physical Status II
- Stable baseline hemodynamics prior to anesthesia
Key exclusion criteria (8 listed)
- Emergency cesarean section
- Fetal distress
- Preeclampsia or eclampsia
- Contraindications to spinal anesthesia (e.g., coagulopathy, infection at injection site)
- Known allergy to norepinephrine or phenylephrine
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 4mcgNorepinephrine 4 mcg IV bolus diluted in 2 mL normal saline, administered upon onset of hypotension during spinal anesthesia. | Drug | Norepinephrine Group |
| Phenylephrine 50 mcgPhenylephrine 50 mcg IV bolus diluted in 2 mL normal saline, administered upon onset of hypotension during spinal anesthesia. | Drug | Phenylephrine Group |
Primary outcome
Change in Systolic Blood Pressure (SBP) After Vasopressor Administration
Time frame: Baseline to 2 minutes post-administration (T0-T2)
Change in systolic blood pressure measured before vasopressor administration (T0-T1) and two minutes after administration (T2) in response to intravenous bolus of norepinephrine 4 mcg or phenylephrine 50 mcg during spinal anesthesia-induced hypotension in cesarean section patients.
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 4 Sep 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine 4mcg and Phenylephrine 50 mcg in people with Hypotenstion and Cesarean Resection, run by Universitas Sumatera Utara at 1 site in Indonesia.
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 6 inclusion and 8 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 4 Sep 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 Indonesia. 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.
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?
Change in Systolic Blood Pressure (SBP) After Vasopressor Administration (time frame: Baseline to 2 minutes post-administration (T0-T2)). 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 4 Sep 2025.