HypotensionPhase 4NCT05248932
Norepinephrine to Prevent Hypotension in Ceasrean Delivery
A Phase 4 study testing Norepinephrine bolus, cardiometry and Norepinephrine infusion in people with Hypotension and Cesarean Section Complications, run by Menoufia University at 1 site in Egypt.
Trial summary
This study will be conducted on 40 healthy women having spinal anesthesia for elective cesarean delivery in the operating rooms at Menoufia university hospital. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotension, Cesarean Section Complications
- What is being tested?
- Norepinephrine bolus, cardiometry and Norepinephrine infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2021to 20 Jun 2022
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I \& II
- Non laboring
- Normotensive
- Elective cesarean delivery under spinal anesthesia.
- Baseline systolic blood pressure 90-140 mm Hg
Who cannot join
- Known fetal abnormality.
- Preexisting or pregnancy-induced hypertension.
- Known cardiovascular or cerebrovascular disease.
- Thrombocytopenia, coagulopathy or any contraindication to spinal anesthesia.
- Weight <50 or >100 kg, height <140 or >180 cm.
- Inability or refusal to give informed consent
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, University Hospitals
Shibīn al Kawm, Menoufia, 32511
About this study
Official title: Role of Norepinephrine Infusion in Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery.
This study will be conducted on 40 healthy women having spinal anesthesia for elective cesarean delivery in the operating rooms at Menoufia university hospital.
Read the detailed description
Informed written consent will be taken from all subjects included in the study after approval of the study by the local ethical committee.
All subjects will be subjected to thorough history taking with risk factors, medical histories, general clinical examination, local clinical examination, laboratory investigations as complete blood count and coagulation profile.
Standardized anesthetic care will be provided according to institutional standards, which include fasting, antacid premedication and noninvasive hemodynamic monitoring After arrival in the operating room, patients will be positioned supine with left lateral tilt, pulse oximeter, ECG leads, non-invasive blood pressure cuff and cardiometry leads (4 surface ECG electrodes is attached to the left side of the neck and the lower thorax (approximately at the level of the xiphoid process) will be attached to patient for monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance and values will be recorded as a baseline and every 10 minutes after intrathecal injection.
10 ml/kg/hr lactated ringer solution will be infused to all patients through an 18 gauge intravenous cannula for 30 minutes as a preload before spinal anesthesia then reduced to maintenance infusion of 6 ml/kg/hr.
Patients will be then placed in sitting position. After skin disinfection and skin infiltration with lidocaine 1%, spinal anesthesia will be performed with 2ml 0.5% hyperbaric bupivacaine (10 mg) in addition to 0.5 ml fentanyl (25 μg) at L3-L4 or L4-L5.
The patient will be then returned to the left-tilted supine position. The study drug regimen will be started immediately after intrathecal injection.
- Conditions
- Hypotension, Cesarean Section Complications
- Being tested
- Norepinephrine bolus, cardiometry, Norepinephrine infusion
- Keywords
- hypotension, norepinephrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine bolusDrug
5 microgram bolus therapy
cardiometryDevice
cardiac output, stroke volume and fluid responsiveness monitoring
Norepinephrine infusionDrug
2.5 microgram/min infusion
| Study group | Role | What they receive |
|---|---|---|
| infusion | Active comparator | patients will receive an infusion of norepinephrine that will be started at 2.5μg/min immediately after intrathecal injection and then manually adjusted according to monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance by using cardiometry, with the objective of maintaining values near baseline Receives: Device: cardiometry; Drug: Norepinephrine infusion |
| bolus | Active comparator | patient with no prophylactic vasopressor and a bolus of 5 μg norepinephrine will be given whenever systolic BP decreases to <80% of the baseline value. Receives: Drug: Norepinephrine bolus; Device: cardiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
throracic volume variations change from baseline
using cardiometry
Measured: every 10 minutes up to 1 hour
cardiac index change from baseline
using cardiometry
Measured: every 10 minutes up to 1 hour
systemic vascular resistance change from baseline
using cardiometry
Measured: every 10 minutes up to 1 hour
stroke volume variation change from baseline
using cardiometry
Measured: every 10 minutes and up to 1 hour
Secondary outcomes (4)
umblical cord gases sample
Measured: in the first minute after delivery
APGAR score
score from 1 to 10 with the highest score better for neonatal outcome
Measured: after 5 minutes and 10 minutes after delivery
Non invasive MEAN blood pressure
change from baseline
Measured: every 10 minutes and up tp 1 hour
Heart rate
change from baseline
Measured: every 10 minutes and up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start20 Jan 2021
- Primary completion20 May 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa saieed fahim mansour, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248932
- Sponsor's protocol ID
- 19919ANET33
- Status last verified
- Oct 2022
- First submitted
- 29 Dec 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Norepinephrine Infusion in Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery.
- ClinicalTrials.gov ID
- NCT05248932
- Acronym / sponsor ID
- 19919ANET33
- Conditions
- Hypotension, Cesarean Section Complications
- Keywords
- hypotension, norepinephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 21 Feb 2022 (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 study will be conducted on 40 healthy women having spinal anesthesia for elective cesarean delivery in the operating rooms at Menoufia university hospital.
Detailed description
Informed written consent will be taken from all subjects included in the study after approval of the study by the local ethical committee.
All subjects will be subjected to thorough history taking with risk factors, medical histories, general clinical examination, local clinical examination, laboratory investigations as complete blood count and coagulation profile.
Standardized anesthetic care will be provided according to institutional standards, which include fasting, antacid premedication and noninvasive hemodynamic monitoring After arrival in the operating room, patients will be positioned supine with left lateral tilt, pulse oximeter, ECG leads, non-invasive blood pressure cuff and cardiometry leads (4 surface ECG electrodes is attached to the left side of the neck and the lower thorax (approximately at the level of the xiphoid process) will be attached to patient for monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance and values will be recorded as a baseline and every 10 minutes after intrathecal injection.
10 ml/kg/hr lactated ringer solution will be infused to all patients through an 18 gauge intravenous cannula for 30 minutes as a preload before spinal anesthesia then reduced to maintenance infusion of 6 ml/kg/hr.
Patients will be then placed in sitting position. After skin disinfection and skin infiltration with lidocaine 1%, spinal anesthesia will be performed with 2ml 0.5% hyperbaric bupivacaine (10 mg) in addition to 0.5 ml fentanyl (25 μg) at L3-L4 or L4-L5.
The patient will be then returned to the left-tilted supine position. The study drug regimen will be started immediately after intrathecal injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infusion | Active comparator | Device: cardiometry, Drug: Norepinephrine infusionpatients will receive an infusion of norepinephrine that will be started at 2.5μg/min immediately after intrathecal injection and then manually adjusted according to monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance by using cardiometry, with the objective of maintaining values near baseline |
| bolus | Active comparator | Drug: Norepinephrine bolus, Device: cardiometrypatient with no prophylactic vasopressor and a bolus of 5 μg norepinephrine will be given whenever systolic BP decreases to <80% of the baseline value. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ASA I \& II
- Non laboring
- Normotensive
- Elective cesarean delivery under spinal anesthesia.
- Baseline systolic blood pressure 90-140 mm Hg
Key exclusion criteria (6 listed)
- Known fetal abnormality.
- Preexisting or pregnancy-induced hypertension.
- Known cardiovascular or cerebrovascular disease.
- Thrombocytopenia, coagulopathy or any contraindication to spinal anesthesia.
- Weight <50 or >100 kg, height <140 or >180 cm.
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 bolus5 microgram bolus therapy | Drug | bolus |
| cardiometrycardiac output, stroke volume and fluid responsiveness monitoring | Device | bolus, infusion |
| Norepinephrine infusion2.5 microgram/min infusion | Drug | infusion |
Primary outcome
throracic volume variations change from baseline
Time frame: every 10 minutes up to 1 hour
using cardiometry
cardiac index change from baseline
Time frame: every 10 minutes up to 1 hour
using cardiometry
systemic vascular resistance change from baseline
Time frame: every 10 minutes up to 1 hour
using cardiometry
stroke volume variation change from baseline
Time frame: every 10 minutes and up to 1 hour
using cardiometry
4 secondary outcomes
umblical cord gases sample
Time frame: in the first minute after delivery
APGAR score
Time frame: after 5 minutes and 10 minutes after delivery
Non invasive MEAN blood pressure
Time frame: every 10 minutes and up tp 1 hour
Heart rate
Time frame: every 10 minutes and up to 1 hour
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 14 Oct 2022.
- Individual participant dataSharing planned: No
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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.
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 Phase 4 study testing Norepinephrine bolus, cardiometry and Norepinephrine infusion in people with Hypotension and Cesarean Section Complications, run by Menoufia University at 1 site in Egypt.
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 6 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 14 Oct 2022. 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 Egypt. 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?
throracic volume variations change from baseline (time frame: every 10 minutes up to 1 hour). 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 14 Oct 2022.