HypotensionNCT06512415
10 Vs.15 mcg Norepinephrine Bolus in Severe Maternal Hypotension During Cesarean Delivery
A study testing 10 mcg Norepinephrine and 15 mcg Norepinephrine in people with Hypotension and Spinal Anesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
Data regarding the optimum dose of norepinephrine for management of severe maternal hypotension is lacking. A previous report showed that the use of 10-mcg norepinephrine bolus was not superior to the 5-mcg bolus in the management of severe hypotension in addition the incidence of reactive bradycardia and hypertension… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hypotension, Spinal Anesthesia, Cesarean Section
- What is being tested?
- 10 mcg Norepinephrine and 15 mcg Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2024to Dec 2024
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- full-term singleton pregnant women
- American society of anesthesiologist II, scheduled for elective cesarean delivery,
Who cannot join
- Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias),
- hypertensive disorders of pregnancy,
- peripartum bleeding,
- coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or any contraindication to regional anesthesia,
- baseline systolic blood pressure (SBP) < 100 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing 10- Versus 15-mcg Norepinephrine Bolus for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery: A Randomized, Controlled Trial
Data regarding the optimum dose of norepinephrine for management of severe maternal hypotension is lacking. A previous report showed that the use of 10-mcg norepinephrine bolus was not superior to the 5-mcg bolus in the management of severe hypotension in addition the incidence of reactive bradycardia and hypertension was comparable in the two doses. Therefore, we hypothesize that using a higher dose of norepinephrine (15 mcg) would increase the success rate of management of severe hypotensive episode.
Read the detailed description
Upon arrival to the operating room, the patient will be in supine position with left uterine displacement using a wedge below the right buttock. Routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and the patients will receive 10 mg metoclopramide. Baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval.
Lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes as a co-load; spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.
After subarachnoid block, mothers will be placed in the supine position with left-lateral tilt.
Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic; and will be confirmed if sensory block level is at T4.
The patient would receive the study drug only if she developed severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading) as her first hypotensive episode. The management of the hypotensive episode will be considered successful if the systolic blood pressure is > 80% of the baseline within 2 mins of the bolus. If the bolus failed, norepinephrine bolus of 5 mcg will be given.
Any other hypotensive episode (systolic blood pressure <80% of baseline) will be managed with norepinephrine bolus of 5 mcg.
Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by IV atropine bolus (0.5 mg) will be administered.
Fluid administration will be continued up to a maximum of 1.5 liters. An oxytocin bolus (1 IU) will be delivered over five seconds after delivery then infused at a rate of 2.5-7.5 IU/hour.
- Conditions
- Hypotension, Spinal Anesthesia, Cesarean Section
- Being tested
- 10 mcg Norepinephrine, 15 mcg Norepinephrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mcg NorepinephrineDrug
The assigned dose (10 mcg) will be diluted with normal saline in a 10-cc syringe
15 mcg NorepinephrineDrug
The assigned dose (15 mcg) will be diluted with normal saline in a 10-cc syringe.
| Study group | Role | What they receive |
|---|---|---|
| 10 mcg group | Active comparator | patient will receive the study dry once developed severe post-spinal hypotension Receives: Drug: 10 mcg Norepinephrine |
| 15 mcg group | Active comparator | patients will receive the study dry once developed severe post-spinal hypotension Receives: Drug: 15 mcg Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of successful management of severe post-spinal hypotension
systolic blood pressure >80% of baseline after drug bolus
Measured: 1 min after spinal anesthesia until 5 min after the delivery
Secondary outcomes (7)
time to severe hypotensive episode
min
Measured: 1 min after spinal anesthesia until 5 min after the delivery
reactive bradycardia
heart rate <55 beat/min
Measured: 1 min after spinal anesthesia until 5 min after the delivery
reactive hypertension
systolic blood pressure >120% of baseline
Measured: 1 min after spinal anesthesia until 5 min after the delivery
umbilical blood pH
umbilical artery sample
Measured: 5 min after delivery
Apgar score
assess Breathing effort, Heart rate, Muscle tone, Reflexes, Skin color, Each category is scored with 0, 1, or 2
Measured: 5 min after delivery
systolic blood pressure
mmHg
Measured: baseline, 1 min after spinal anesthesia until 5 min after the delivery
heart rate
beat/min
Measured: baseline, 1 min after spinal anesthesia until 5 min after the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
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 Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512415
- Sponsor's protocol ID
- MS-421-2022
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing 10- Versus 15-mcg Norepinephrine Bolus for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06512415
- Acronym / sponsor ID
- MS-421-2022
- Conditions
- Hypotension, Spinal Anesthesia, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Jul 2024 (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.
Data regarding the optimum dose of norepinephrine for management of severe maternal hypotension is lacking. A previous report showed that the use of 10-mcg norepinephrine bolus was not superior to the 5-mcg bolus in the management of severe hypotension in addition the incidence of reactive bradycardia and hypertension was comparable in the two doses. Therefore, we hypothesize that using a higher dose of norepinephrine (15 mcg) would increase the success rate of management of severe hypotensive episode.
Detailed description
Upon arrival to the operating room, the patient will be in supine position with left uterine displacement using a wedge below the right buttock. Routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and the patients will receive 10 mg metoclopramide. Baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval.
Lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes as a co-load; spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.
After subarachnoid block, mothers will be placed in the supine position with left-lateral tilt.
Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic; and will be confirmed if sensory block level is at T4.
The patient would receive the study drug only if she developed severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading) as her first hypotensive episode. The management of the hypotensive episode will be considered successful if the systolic blood pressure is > 80% of the baseline within 2 mins of the bolus. If the bolus failed, norepinephrine bolus of 5 mcg will be given.
Any other hypotensive episode (systolic blood pressure <80% of baseline) will be managed with norepinephrine bolus of 5 mcg.
Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by IV atropine bolus (0.5 mg) will be administered.
Fluid administration will be continued up to a maximum of 1.5 liters. An oxytocin bolus (1 IU) will be delivered over five seconds after delivery then infused at a rate of 2.5-7.5 IU/hour.
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 |
|---|---|---|
| 10 mcg group | Active comparator | Drug: 10 mcg Norepinephrinepatient will receive the study dry once developed severe post-spinal hypotension |
| 15 mcg group | Active comparator | Drug: 15 mcg Norepinephrinepatients will receive the study dry once developed severe post-spinal hypotension |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- full-term singleton pregnant women
- American society of anesthesiologist II, scheduled for elective cesarean delivery,
Key exclusion criteria (5 listed)
- Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias),
- hypertensive disorders of pregnancy,
- peripartum bleeding,
- coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or any contraindication to regional anesthesia,
- baseline systolic blood pressure (SBP) < 100 mmHg
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 |
|---|---|---|
| 10 mcg NorepinephrineThe assigned dose (10 mcg) will be diluted with normal saline in a 10-cc syringe | Drug | 10 mcg group |
| 15 mcg NorepinephrineThe assigned dose (15 mcg) will be diluted with normal saline in a 10-cc syringe. | Drug | 15 mcg group |
Primary outcome
the incidence of successful management of severe post-spinal hypotension
Time frame: 1 min after spinal anesthesia until 5 min after the delivery
systolic blood pressure >80% of baseline after drug bolus
7 secondary outcomes
time to severe hypotensive episode
Time frame: 1 min after spinal anesthesia until 5 min after the delivery
reactive bradycardia
Time frame: 1 min after spinal anesthesia until 5 min after the delivery
reactive hypertension
Time frame: 1 min after spinal anesthesia until 5 min after the delivery
umbilical blood pH
Time frame: 5 min after delivery
Apgar score
Time frame: 5 min after delivery
systolic blood pressure
Time frame: baseline, 1 min after spinal anesthesia until 5 min after the delivery
heart rate
Time frame: baseline, 1 min after spinal anesthesia until 5 min after the delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request
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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 study testing 10 mcg Norepinephrine and 15 mcg Norepinephrine in people with Hypotension and Spinal Anesthesia, run by Cairo 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. 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.
Are results available for this study?
Results are not available in the source record.
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?
the incidence of successful management of severe post-spinal hypotension (time frame: 1 min after spinal anesthesia until 5 min after the delivery). 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 22 Jul 2024.