Cesarean Section ComplicationsPhase 4NCT03182088
Norepinephrine Infusion Different Doses in Cesarean Delivery
A Phase 4 study testing norepinephrine infusion (0.025 mcg/Kg/min), norepinephrine infusion (0.050 mcg/Kg/min) and norepinephrine infusion (0.075 mcg/Kg/min) in people with Cesarean Section Complications, run by Cairo University at 1 site in Egypt.
Trial summary
three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- norepinephrine infusion (0.025 mcg/Kg/min), norepinephrine infusion (0.050 mcg/Kg/min) and norepinephrine infusion (0.075 mcg/Kg/min)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2017to 30 Dec 2017
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- full term
- singleton
- pregnant women
- scheduled for elective cesarean delivery
Who cannot join
- cardiac morbidities
- hypertensive disorders of pregnancy
- peripartum bleeding
- baseline systolic blood pressure (SBP) < 100 mmHg
- body mass index > 35 will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Norepinephrine Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Dose Finding Trial.
three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery.
Read the detailed description
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD.
Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonist activity in addition to a weak β adrenergic agonist activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia).
Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known.
In this study, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against PSH during CD.
- Conditions
- Cesarean Section Complications
- Being tested
- norepinephrine infusion (0.025 mcg/Kg/min), norepinephrine infusion (0.050 mcg/Kg/min), norepinephrine infusion (0.075 mcg/Kg/min), Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
norepinephrine infusion (0.025 mcg/Kg/min)Drug
Also called noradrenaline infusion
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine bitartrate infusion of (0.05 mcg/Kg/min) equivalent to norepinephrine base of (0.025 mcg/Kg/min)
norepinephrine infusion (0.050 mcg/Kg/min)Drug
Also called noradrenaline infusion
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.1 mcg/Kg/min) equivalent to norepinephrine base of (0.050 mcg/Kg/min)
norepinephrine infusion (0.075 mcg/Kg/min)Drug
Also called noradrenaline infusion
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.15 mcg/Kg/min) equivalent to norepinephrine base of (0.075 mcg/Kg/min).
BupivacaineDrug
Also called spinal anesthesia, Heavy marcaine
The patient will receive spinal anesthesia using Bupivacaine (10 mg).
| Study group | Role | What they receive |
|---|---|---|
| 0.025 mcg /Kg/min group | Experimental | The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.05 mcg/Kg/min) equivalent to norepinephrine infusion (0.025 mcg/Kg/min). Receives: Drug: norepinephrine infusion (0.025 mcg/Kg/min); Drug: Bupivacaine |
| 0.050 mcg/Kg/min group | Experimental | The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.1 mcg/Kg/min) equivalent to norepinephrine infusion (0.050 mcg/Kg/min). Receives: Drug: norepinephrine infusion (0.050 mcg/Kg/min); Drug: Bupivacaine |
| 0.075 mcg/Kg/min group | Experimental | The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.15 mcg/Kg/min) equivalent to norepinephrine infusion (0.075 mcg/Kg/min) Receives: Drug: norepinephrine infusion (0.075 mcg/Kg/min); Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postspinal hypotension
The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group
Measured: 30 minutes after spinal anesthesia
Secondary outcomes (11)
severe postspinal hypotension
The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group
Measured: 30 minutes after spinal anesthesia
Post-delivery hypotension
number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading after delivery of the fetus and starting oxytocin infusion)
Measured: 10 minutes after delivery
systolic blood pressure
systolic blood pressure measured in mmHg
Measured: 60 minutes after spinal block
diastolic blood pressure
diastolic blood pressure measured in mmHg
Measured: 60 minutes after spinal block
heart rate
heart rate measured in beats per minute
Measured: 60 minutes after spinal block
intraoperative hypertension
number of patients who develop intraoperive hypertension (defined as increased systolic blood pressure by more than 20% of the baseline reading) divided by the total number of patients in the group
Measured: 60 minutes after spinal block
incidence of nausea and vomiting
number of patients who develop nausea and vomiting divided by the total number of patients in the group
Measured: 60 minutes after spinal block
ephedrine consumption
total amount of ephedrine consumed during the operation (measured in milligrams)
Measured: 60 minutes after spinal block
Atropine consumption
total amount of atropine consumed during the operation (measured in milligrams)
Measured: 60 minutes after spinal block
APGAR score
APGAR score for detection of the well being of the fetus
Measured: 1 minute after delivery
APGAR score
APGAR score for detection of the well being of the fetus
Measured: 10 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start15 Jun 2017
- Primary completion25 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ahmed Mukhtar, Professor, Study director, Head of research committee section in anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182088
- Sponsor's protocol ID
- N-49-2017
- Status last verified
- Aug 2018
- First submitted
- 7 Jun 2017
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Dose Finding Trial.
- ClinicalTrials.gov ID
- NCT03182088
- Acronym / sponsor ID
- N-49-2017
- Conditions
- Cesarean Section Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 25 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 9 Jun 2017 (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.
three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery.
Detailed description
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD.
Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonist activity in addition to a weak β adrenergic agonist activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia).
Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known.
In this study, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against PSH during CD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.025 mcg /Kg/min group | Experimental | Drug: norepinephrine infusion (0.025 mcg/Kg/min), Drug: BupivacaineThe patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.05 mcg/Kg/min) equivalent to norepinephrine infusion (0.025 mcg/Kg/min). |
| 0.050 mcg/Kg/min group | Experimental | Drug: norepinephrine infusion (0.050 mcg/Kg/min), Drug: BupivacaineThe patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.1 mcg/Kg/min) equivalent to norepinephrine infusion (0.050 mcg/Kg/min). |
| 0.075 mcg/Kg/min group | Experimental | Drug: norepinephrine infusion (0.075 mcg/Kg/min), Drug: BupivacaineThe patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.15 mcg/Kg/min) equivalent to norepinephrine infusion (0.075 mcg/Kg/min) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- full term
- singleton
- pregnant women
- scheduled for elective cesarean delivery
Key exclusion criteria (5 listed)
- cardiac morbidities
- hypertensive disorders of pregnancy
- peripartum bleeding
- baseline systolic blood pressure (SBP) < 100 mmHg
- body mass index > 35 will be excluded from the study.
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 infusion (0.025 mcg/Kg/min)Also: noradrenaline infusionThe patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine bitartrate infusion of (0.05 mcg/Kg/min) equivalent to norepinephrine base of (0.025 mcg/Kg/min) | Drug | 0.025 mcg /Kg/min group |
| norepinephrine infusion (0.050 mcg/Kg/min)Also: noradrenaline infusionThe patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.1 mcg/Kg/min) equivalent to norepinephrine base of (0.050 mcg/Kg/min) | Drug | 0.050 mcg/Kg/min group |
| norepinephrine infusion (0.075 mcg/Kg/min)Also: noradrenaline infusionThe patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.15 mcg/Kg/min) equivalent to norepinephrine base of (0.075 mcg/Kg/min). | Drug | 0.075 mcg/Kg/min group |
| BupivacaineAlso: spinal anesthesia, Heavy marcaineThe patient will receive spinal anesthesia using Bupivacaine (10 mg). | Drug | 0.025 mcg /Kg/min group, 0.050 mcg/Kg/min group, 0.075 mcg/Kg/min group |
Primary outcome
postspinal hypotension
Time frame: 30 minutes after spinal anesthesia
The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group
11 secondary outcomes
severe postspinal hypotension
Time frame: 30 minutes after spinal anesthesia
Post-delivery hypotension
Time frame: 10 minutes after delivery
systolic blood pressure
Time frame: 60 minutes after spinal block
diastolic blood pressure
Time frame: 60 minutes after spinal block
heart rate
Time frame: 60 minutes after spinal block
intraoperative hypertension
Time frame: 60 minutes after spinal block
incidence of nausea and vomiting
Time frame: 60 minutes after spinal block
ephedrine consumption
Time frame: 60 minutes after spinal block
Atropine consumption
Time frame: 60 minutes after spinal block
APGAR score
Time frame: 1 minute after delivery
APGAR score
Time frame: 10 minutes after delivery
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 24 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Not yet recruiting
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
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.
Ahmed Mukhtar, Professor study director
Head of research committee section in anesthesia department
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 infusion (0.025 mcg/Kg/min), norepinephrine infusion (0.050 mcg/Kg/min) and norepinephrine infusion (0.075 mcg/Kg/min) in people with Cesarean Section Complications, 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 4 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: finished, as of the sponsor's last update on 24 Aug 2018. 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?
postspinal hypotension (time frame: 30 minutes after spinal anesthesia). 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 24 Aug 2018.